Systems and methods for processing, transmitting and displaying sensor data

ABSTRACT

Systems and methods for continuous measurement of an analyte in a host are provided. The system generally includes a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and a sensor electronics module physically connected to the continuous analyte sensor during sensor use, wherein the sensor electronics module is further configured to directly wirelessly communicate displayable sensor information to a plurality of different types of display devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/390,304, filed on Feb. 20, 2009, which claims priority under 35U.S.C. §119(e) to U.S. Provisional Application No. 61/030,499, filed onFeb. 21, 2008, the disclosures of which are hereby expresslyincorporated by reference in their entirety and are hereby expresslymade a portion of this application. U.S. application Ser. No. 12/390,304is related to and incorporates by reference in their entirety thedisclosures of commonly owned U.S. application Ser. No. 12/390,205,filed on Feb. 20, 2009, and U.S. application Ser. No. 12/390,290, filedon Feb. 20, 2009.

FIELD OF THE INVENTION

The present invention relates generally to systems and methods forprocessing, transmitting and displaying data received from an analytesensor, such as a glucose sensor.

BACKGROUND OF THE INVENTION

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which causes an arrayof physiological derangements (kidney failure, skin ulcers, or bleedinginto the vitreous of the eye) associated with the deterioration of smallblood vessels. A hypoglycemic reaction (low blood sugar) may be inducedby an inadvertent overdose of insulin, or after a normal dose of insulinor glucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

Conventionally, a diabetic person carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a diabeticwill normally only measure his or her glucose level two to four timesper day. Unfortunately, these time intervals are spread so far apartthat the diabetic will likely find out too late, sometimes incurringdangerous side effects, of a hyperglycemic or hypoglycemic condition. Infact, it is not only unlikely that a diabetic will take a timely SMBGvalue, but additionally the diabetic will not know if his blood glucosevalue is going up (higher) or down (lower) based on conventionalmethods.

Consequently, a variety of non-invasive, transdermal (e.g.,transcutaneous) and/or implantable electrochemical sensors are beingdeveloped for continuously detecting and/or quantifying blood glucosevalues. These devices generally transmit raw or minimally processed datafor subsequent analysis at a remote device, which can include a display.

SUMMARY OF THE INVENTION

In one embodiment, a system for continuous measurement of an analyte ina host comprises a continuous analyte sensor configured to measure aconcentration of an analyte in a host, a sensor electronics modulephysically connected to the continuous analyte sensor during operationof the continuous analyte sensor, wherein the sensor electronics moduleis configured to process a data stream associated with an analyteconcentration measured by the continuous analyte sensor and to generatedisplayable sensor information based on at least some sensor data of thedata stream. In one embodiment, the sensor electronics module comprisesa storage device configured to store at least some of the displayablesensor information and a telemetry module configured to wirelesslytransmit a first portion of the displayable sensor information to afirst display device, wherein the first portion of displayable sensorinformation is formatted for display on the first display device, and towirelessly transmit a second portion of the displayable sensorinformation to a second display device, wherein the second portion ofdisplayable sensor information is formatted for display on the seconddisplay device.

In one embodiment, a computerized method for customizing displayablesensor information that is transmitted to display devices comprisesdetermining analyte concentration data associated with a host based atleast on sensor data from a continuous analyte sensor associated withthe host, generating displayable sensor information based on at leastsome of the analyte concentration data, storing at least some of thedisplayable sensor information on a storage device, wirelesslytransmitting a first portion of the displayable sensor information to afirst display device and wirelessly transmitting a second portion of thedisplayable sensor information to a second display device. In oneembodiment the first portion of displayable sensor information isformatted for display on the first display device and the second portionof displayable sensor information is formatted for display on the seconddisplay device.

In one embodiment, a computer readable medium stores software codethereon, the software code configured for execution by one or moreprocessors of a sensor electronics module configured for coupling to ananalyte sensor that is attached to a host, wherein the software code, ifexecuted by the one or more processors, causes the sensor electronicsmodule to perform a method comprising determining analyte concentrationdata associated with a host based at least on sensor data from acontinuous analyte sensor associated with the host, generatingdisplayable sensor information based on at least some of the analyteconcentration data, storing at least some of the displayable sensorinformation on a storage device, wirelessly transmitting a first portionof the displayable sensor information to a first display device, andwirelessly transmitting a second portion of the displayable sensorinformation to a second display device. In one embodiment, the firstportion of displayable sensor information is formatted for display onthe first display device and the second portion of displayable sensorinformation is formatted for display on the second display device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram illustrating one embodiment of a continuous analytesensor system including a sensor electronics module.

FIG. 2A is a block diagram illustrating one embodiment of the sensorelectronics module of FIG. 1.

FIG. 2B is a perspective view of a sensor system including a mountingunit and sensor electronics module attached thereto according to oneembodiment.

FIG. 2C is a side view of the sensor system of FIG. 2B.

FIG. 3 is a diagram illustrating one embodiment of a sensor electronicsmodule in communication with multiple sensors, including a glucosesensor.

FIG. 4 is a diagram illustrating one embodiment of a sensor electronicsmodule in communication with a combined glucose and temperature sensor,as well as an accelerometer.

FIG. 5A is a diagram illustrating one embodiment of a sensor electronicsmodule directly transmitting data to a first display device andindirectly transmitting data to second and third display devices.

FIG. 5B is a diagram illustrating one embodiment of the sensorelectronics module configured to transmit control signals to biologicaldevices coupled to the host.

FIG. 5C is a diagram illustrating one embodiment of the sensorelectronics module in communication with multiple sensors, wherein thesensor electronics module transmits data packages to multiple displaydevices via multiple networks, such as the Internet and a telephonenetwork.

FIG. 6 is a flowchart illustrating one embodiment of a method ofgenerating customizable data packages for delivery to respective displaydevices, such as based on user-defined delivery options.

FIG. 7 is a flowchart illustrating one embodiment of a method ofgenerating customizable data packages for delivery to requesting displaydevices, such as in response to receiving a request from a displaydevice.

FIG. 8 is a flowchart illustrating what embodiment of a method ofselecting delivery options for a data package based on one or more of aplurality of attributes.

FIG. 9 is a flowchart illustrating one embodiment of a method ofgenerating and transmitting a data package that is customized accordingto a status of the host and/or a status of the receiving display device.

FIGS. 10A and 10B are block diagrams illustrating one embodiment of asensor module that is configured to alternatively couple with each of aplurality of modular devices each having different functionalities.

FIG. 11 illustrates an exemplary user interface for defining alertparameters.

FIG. 12 illustrates an exemplary user interface for defining displaydevice characteristics.

FIG. 13 illustrates an exemplary user interface for establishingdelivery options associated with respective alerts and display devices.

FIG. 14A illustrates a portion of an exemplary alert data structure.

FIG. 14B illustrates a portion of an exemplary delivery options datastructure.

FIG. 15A illustrates a portion of an exemplary device data structure.

FIG. 15B illustrates a portion of another exemplary alert datastructure.

FIG. 16 illustrates a portion of an exemplary multi-sensor alert datastructure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description and examples illustrate some exemplaryembodiments of the disclosed invention in detail. Those of skill in theart will recognize that there are numerous variations and modificationsof this invention that are encompassed by its scope. Accordingly, thedescription of a certain exemplary embodiment should not be deemed tolimit the scope of the present invention.

DEFINITIONS

In order to facilitate an understanding of the systems and methodsdiscussed herein, a number of terms are defined below. The terms definedbelow, as well as other terms used herein, should be construed toinclude the provided definitions, the ordinary and customary meaning ofthe terms, and any other implied meaning for the respective terms. Thus,the definitions below do not limit the meaning of these terms, but onlyprovide exemplary definitions.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-βhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free β-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferring;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbituates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

The term “A/D Converter” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to hardware and/orsoftware that converts analog electrical signals into correspondingdigital signals.

The terms “processor module,” “microprocessor” and “processor” as usedherein are broad terms and are to be given their ordinary and customarymeaning to a person of ordinary skill in the art (and are not to belimited to a special or customized meaning), and furthermore referwithout limitation to a computer system, state machine, and the likethat performs arithmetic and logic operations using logic circuitry thatresponds to and processes the basic instructions that drive a computer.

The terms “sensor data”, as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and are not to be limited to a special or customizedmeaning), and furthermore refers without limitation to any dataassociated with a sensor, such as a continuous analyte sensor. Sensordata includes a raw data stream, or simply data stream, of analog ordigital signal directly related to a measured analyte from an analytesensor (or other signal received from another sensor), as well ascalibrated and/or filtered raw data. In one example, the sensor datacomprises digital data in “counts” converted by an A/D converter from ananalog signal (e.g., voltage or amps) and includes one or more datapoints representative of a glucose concentration. Thus, the terms“sensor data point” and “data point” refer generally to a digitalrepresentation of sensor data at a particular time. The term broadlyencompasses a plurality of time spaced data points from a sensor, suchas a from a substantially continuous glucose sensor, which comprisesindividual measurements taken at time intervals ranging from fractionsof a second up to, e.g., 1, 2, or 5 minutes or longer. In anotherexample, the sensor data includes an integrated digital valuerepresentative of one or more data points averaged over a time period.Sensor data may include calibrated data, smoothed data, filtered data,transformed data, and/or any other data associated with a sensor.

The term “calibration” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a process of determining arelationship between a raw data stream and corresponding reference data,which can be used to convert raw data into calibrated data (definedbelow). In some embodiments, such as continuous analyte sensors, forexample, calibration can be updated or recalibrated over time as changesin the relationship between the raw data and reference data occur, forexample, due to changes in sensitivity, baseline, transport, metabolism,and the like.

The terms “calibrated data” and “calibrated data stream” as used hereinare broad terms and are to be given their ordinary and customary meaningto a person of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto data that has been transformed from its raw state to another stateusing a function, for example a conversion function, to provide ameaningful value to a user.

The terms “smoothed data” and “filtered data” as used herein are broadterms and are to be given their ordinary and customary meaning to aperson of ordinary skill in the art (and are not to be limited to aspecial or customized meaning), and furthermore refer without limitationto data that has been modified to make it smoother and more continuousand/or to remove or diminish outlying points, for example, by performinga moving average of the raw data stream. Examples of data filtersinclude FIR (finite impulse response), IIR (infinite impulse response),moving average filters, and the like.

The terms “smoothing” and “filtering” as used herein are broad terms andare to be given their ordinary and customary meaning to a person ofordinary skill in the art (and are not to be limited to a special orcustomized meaning), and furthermore refer without limitation to amathematical computation that attenuates or normalizes components of asignal, such as reducing noise errors in a raw data stream. In someembodiments, smoothing refers to modification of a data stream to makeit smoother and more continuous or to remove or diminish outlying datapoints, for example, by performing a moving average of the raw datastream.

The term “noise signal” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to a signalassociated with noise on the data stream (e.g., non-analyte relatedsignal). The noise signal can be determined by filtering and/oraveraging, for example. In some embodiments, the noise signal is asignal residual, delta residual (difference of residual), absolute deltaresidual, and/or the like, which are described in more detail elsewhereherein.

The term “algorithm” as used herein is a broad term and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a computational process(associated with computer programming or other written instructions)involved in transforming information from one state to another.

The term “matched data pairs” as used herein is a broad term and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to reference data(for example, one or more reference analyte data points) matched withsubstantially time corresponding sensor data (for example, one or moresensor data points).

The term “counts” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a unit of measurement of adigital signal. In one example, a raw data stream measured in counts isdirectly related to a voltage (e.g., converted by an A/D converter),which is directly related to current from the working electrode. Inanother example, counter electrode voltage measured in counts isdirectly related to a voltage.

The term “sensor” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to any device (or portion of adevice) that measures a physical quantity and converts it into a signalthat can be processed by analog and/or digital circuitry. Thus, theoutput of a sensor may be an analog and/or digital signal. Examples ofsensors include analyte sensors, glucose sensors, temperature sensors,altitude sensors, accelerometers, and heart rate sensors.

The terms “glucose sensor” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and are not to be limited to a special or customizedmeaning), and furthermore refer without limitation to any sensor bywhich glucose can be quantified (e.g., enzymatic or non-enzymatic). Forexample, some embodiments of a glucose sensor may utilize a membranethat contains glucose oxidase that catalyzes the conversion of oxygenand glucose to hydrogen peroxide and gluconate, as illustrated by thefollowing chemical reaction:

Glucose+O₂→Gluconate+H₂O₂

Because for each glucose molecule metabolized, there is a proportionalchange in the co-reactant O₂ and the product H₂O₂, one can use anelectrode to monitor the current change in either the co-reactant or theproduct to determine glucose concentration.

The terms “coupled”, “operably connected” and “operably linked” as usedherein are broad terms and are to be given their ordinary and customarymeaning to a person of ordinary skill in the art (and are not to belimited to a special or customized meaning), and furthermore referwithout limitation to one or more components being linked to anothercomponent(s), either directly or indirectly, in a manner that allowstransmission of signals between the components. For example, modules ofa computing device that communicate via a common data bus are coupled toone another. As another example, one or more electrodes of a glucosesensor can be used to detect the amount of glucose in a sample andconvert that information into a signal, e.g., an electrical orelectromagnetic signal; the signal can then be transmitted to anelectronic circuit. In this case, the electrode is “operably linked” tothe electronic circuitry, even though the analog signal from theelectrode is transmitted and/or transformed by analog and/or digitalcircuitry before reaching the electronic circuit. These terms are broadenough to include wireless connectivity.

The term “physically connected” as used herein is a broad term and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and are not to be limited to a special or customizedmeaning), and furthermore refers without limitation to one or morecomponents that are connected to another component(s) through directcontact and/or a wired connection, including connecting via one or moreintermediate physically connecting component(s). For example, a glucosesensor may be physically connected to a sensor electronics module, andthus the processor module located therein, either directly or via one ormore electrical connections.

The term “substantially” as used herein is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to being largely butnot necessarily wholly that which is specified.

The term “host” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to mammal, such as a humanimplanted with a device.

The term “continuous analyte sensor” as used herein is a broad term andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation to adevice, or portion of a device, that continuously or continuallymeasures a concentration of an analyte, for example, at time intervalsranging from fractions of a second up to, for example, 1, 2, or 5minutes, or longer. In one exemplary embodiment, a glucose sensorcomprises a continuous analyte sensor, such as is described in U.S. Pat.No. 7,310,544, which is incorporated herein by reference in itsentirety.

The term “continuous analyte sensing” as used herein is a broad term andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation to theperiod in which monitoring of an analyte is continuously or continuallyperformed, for example, at time intervals ranging from fractions of asecond up to, for example, 1, 2, or 5 minutes, or longer. In oneembodiment, a glucose sensor performs continuous analyte sensing inorder to monitor a glucose level in a corresponding host.

The terms “reference analyte monitor,” “reference analyte meter,” and“reference analyte sensor” as used herein are broad terms and are to begiven their ordinary and customary meaning to a person of ordinary skillin the art (and are not to be limited to a special or customizedmeaning), and furthermore refer without limitation to a device thatmeasures a concentration of an analyte and can be used as a referencefor a continuous analyte sensor, for example a self-monitoring bloodglucose meter (SMBG) can be used as a reference for a continuous glucosesensor for comparison, calibration, and the like.

The term “clinical acceptability”, as used herein, is a broad term andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and refers without limitation to determination ofthe risk of inaccuracies to a patient. Clinical acceptability mayconsider a deviation between time corresponding glucose measurements(e.g., data from a glucose sensor and data from a reference glucosemonitor) and the risk (e.g., to the decision making of a diabeticpatient) associated with that deviation based on the glucose valueindicated by the sensor and/or reference data. One example of clinicalacceptability may be 85% of a given set of measured analyte valueswithin the “A” and “B” region of a standard Clarke Error Grid when thesensor measurements are compared to a standard reference measurement.

The term “quality of calibration” as used herein, is a broad term and isto be given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to the statistical associationof matched data pairs in the calibration set used to create theconversion function. For example, an R-value may be calculated for acalibration set to determine its statistical data association, whereinan R-value greater than 0.79 determines a statistically acceptablecalibration quality, while an R-value less than 0.79 determinesstatistically unacceptable calibration quality.

The term “sensor session” as used herein, is a broad term and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to a period of time a sensor isin use, such as but not limited to a period of time starting at the timethe sensor is implanted (e.g., by the host) to removal of the sensor(e.g., removal of the sensor from the host's body and/or removal of thesensor electronics module from the sensor housing).

The terms “noise,” “noise event(s),” “noise episode(s),” “signalartifact(s),” “signal artifact event(s),” and “signal artifactepisode(s)” as used herein are broad terms and are to be given theirordinary and customary meaning to a person of ordinary skill in the art(and are not to be limited to a special or customized meaning), andfurthermore refer without limitation to signal noise that issubstantially non-glucose related, such as interfering species, macro-or micro-motion, ischemia, pH changes, temperature changes, pressure,stress, or even unknown sources of mechanical, electrical and/orbiochemical noise for example.

The term “measured analyte values” as used herein is a broad term and isto be given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to an analyte valueor set of analyte values for a time period for which analyte data hasbeen measured by an analyte sensor. The term is broad enough to includesensor data from the analyte sensor before or after data processing inthe sensor and/or receiver (for example, data smoothing, calibration,and the like).

The term “estimated analyte values” as used herein is a broad term andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation to ananalyte value or set of analyte values, which have been algorithmicallyextrapolated from measured analyte values. In some embodiments,estimated analyte values are estimated for a time period during which nodata exists. However, estimated analyte values can also be estimatedduring a time period for which measured data exists, but is to bereplaced by algorithmically extrapolated (e.g. processed or filtered)data due to noise or a time lag in the measured data, for example.

The term “calibration information” as used herein is a broad term and isto be given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to any informationuseful in calibration of a sensor. Calibration information may includereference data received from a reference analyte monitor, including oneor more reference data points, one or more matched data pairs formed bymatching reference data (e.g., one or more reference glucose datapoints) with substantially time corresponding sensor data (e.g., one ormore continuous sensor data points), a calibration set formed from a setof one or more matched data pairs, a calibration line drawn from thecalibration set, in vitro parameters (e.g., sensor sensitivity), and/ora manufacturing code, for example.

The term “alarm” as used herein is a broad term, and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to an alert or signal, such as anaudible, visual, or tactile signal, triggered in response to one or morealarm conditions. In one embodiment, hyperglycemic and hypoglycemicalarms are triggered when present or predicted clinical danger isassessed based on continuous analyte data.

The term “transformed sensor data” as used herein is a broad term, andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation to anydata that is derived, either fully or in part, from raw sensor data fromone or more sensors. For example, raw sensor data over a time period(e.g., 5 minutes) may be processed in order to generated transformedsensor data including one or more trend indicators (e.g., a 5 minutetrend). Other examples of transformed data include filtered sensor data(e.g., one or more filtered analyte concentration values), calibratedsensor data (e.g., one or more calibrated analyte concentration values),rate of change information, trend information, rate of accelerationinformation, sensor diagnostic information, location information,alarm/alert information, calibration information, and/or the like.

The term “sensor information” as used herein is a broad term, and is tobe given its ordinary and customary meaning to a person of ordinaryskill in the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to informationassociated with measurement, signal processing (including calibration),alarms, data transmission, and/or display associated with a sensor, suchas a continuous analyte sensor. The term is broad enough to include rawsensor data (one or more raw analyte concentration values), as well astransformed sensor data. In some embodiments, sensor informationincludes displayable sensor information.

The term “displayable sensor information” as used herein is a broadterm, and is to be given its ordinary and customary meaning to a personof ordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation toinformation that is transmitted for display on one or more displaydevices. As is discussed elsewhere herein, the content of displayablesensor information that is transmitted to a particular display devicemay be customized for the particular display device. Additionally,formatting of displayable sensor information may be customized forrespective display devices. Displayable sensor information may includeany sensor data, including raw sensor data, transformed sensor data,and/or any information associated with measurement, signal processing(including calibration), and/or alerts associated with one or moresensors.

The term “data package” as used herein is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and furthermore refers without limitation to a combination ofdata that is transmitted to one or more display devices, such as inresponse to triggering of an alert. A data package may includedisplayable sensor information (e.g., that has been selected andformatted for a particular display device) as well as headerinformation, such as data indicating a delivery address, communicationprotocol, etc. Depending on the embodiment, a data package may comprisesmultiple packets of data that are separately transmitted to a displaydevice (and reassembled at the display device) or a single block of datathat is transmitted to the display device. Data packages may beformatted for transmission via any suitable communication protocol,including radio frequency, Bluetooth, universal serial bus, any of thewireless local area network (WLAN) communication standards, includingthe IEEE 802.11, 802.15, 802.20, 802.22 and other 802 communicationprotocols, and/or a proprietary communication protocol.

The term “direct wireless communication” as used herein is a broad term,and is to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation to a datatransmission that goes from one device to another device without anyintermediate data processing (e.g., data manipulation). For example,direct wireless communication between a sensor electronics module and adisplay device occurs when the sensor information transmitted from thesensor electronics module is received by the display device withoutintermediate processing of the sensor information. The term is broadenough to include wireless communication that is transmitted through arouter, a repeater, a telemetry receiver (e.g., configured tore-transmit the sensor information without additional algorithmicprocessing), and the like. The term is also broad enough to includetransformation of data format (e.g., via a Bluetooth receiver) withoutsubstantive transformation of the sensor information itself.

The term “prospective algorithm(s)” as used herein is a broad term, andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation toalgorithms that process sensor information in real-time (e.g.,continuously and/or periodically as sensor data is received from thecontinuous analyte sensor) and provide real-time data output (e.g.,continuously and/or periodically as sensor data is processed in thesensor electronics module).

The term “retrospective algorithm(s)” as used herein is a broad term,and is to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and furthermore refers without limitation toalgorithms that process sensor information in retrospect, (e.g.,analysis of a set of data for a time period previous to the present timeperiod).

As employed herein, the following abbreviations apply: Eq and Eqs(equivalents); mEq (milliequivalents); M (molar); mM (millimolar) μM(micromolar); N (Normal); mol (moles); mmol (millimoles); μmol(micromoles); nmol (nanomoles); g (grams); mg (milligrams); μg(micrograms); Kg (kilograms); L (liters); mL (milliliters); dL(deciliters); μL (microliters); cm (centimeters); mm (millimeters); μm(micrometers); nm (nanometers); h and hr (hours); min. (minutes); s andsec. (seconds); ° C. (degrees Centigrade).

Overview

In some embodiments, a system is provided for continuous measurement ofan analyte in a host that includes: a continuous analyte sensorconfigured to continuously measure a concentration of the analyte in thehost and a sensor electronics module physically connected to thecontinuous analyte sensor during sensor use. In one embodiment, thesensor electronics module includes electronics configured to process adata stream associated with an analyte concentration measured by thecontinuous analyte sensor in order to generate displayable sensorinformation that includes raw sensor data, transformed sensor data,and/or any other sensor data, for example. The sensor electronics modulemay further be configured to generate displayable sensor informationthat is customized for respective display devices, such that differentdisplay devices may receive different displayable sensor information.

Alerts

In one embodiment, one or more alerts are associated with a sensorelectronics module. For example, each alert may include one or morealert conditions that indicate when the respective alert has beentriggered. For example, a hypoglycemic alert may include alertconditions indicating a minimum glucose level. The alert conditions mayalso be based on transformed sensor data, such as trending data, and/orsensor data from multiple different sensors (e.g. an alert may be basedon sensor data from both a glucose sensor and a temperature sensor). Forexample, a hypoglycemic alert may include alert conditions indicating aminimum required trend in the host's glucose level that must be presentbefore triggering the alert. The term “trend,” as used herein refersgenerally to data indicating some attribute of data that is acquiredover time, e.g., such as calibrated or filtered data from a continuousglucose sensor. A trend may indicate amplitude, rate of change,acceleration, direction, etc., of data, such as sensor data, includingtransformed or raw sensor data.

In one embodiment, each of the alerts is associated with one or moreactions that are to be performed in response to triggering of the alert.Alert actions may include, for example, activating an alarm, such asdisplaying information on a display of the sensor electronics module oractivating an audible or vibratory alarm coupled to the sensorelectronics module, and/or transmitting data to one or more displaydevices external to the sensor electronics module. For any deliveryaction that is associated with a triggered alert, one or more deliveryoptions define the content and/or format of the data to be transmitted,the device to which the data is to be transmitted, when the data is tobe transmitted, and/or a communication protocol for delivery of thedata.

In one embodiment, multiple delivery actions (each having respectivedelivery options) may be associated with a single alert such thatdisplayable sensor information having different content and formatting,for example, is transmitted to respective display devices in response totriggering of a single alert. For example, a mobile telephone mayreceive a data package including minimal displayable sensor information(that may be formatted specifically for display on the mobiletelephone), while a desktop computer may receive a data packageincluding most (or all) of the displayable sensor information that isgenerated by the sensor electronics module in response to triggering ofa common alert. Advantageously, the sensor electronics module is nottied to a single display device, rather it is configured to communicatewith a plurality of different display devices directly, systematically,simultaneously (e.g., via broadcasting), regularly, periodically,randomly, on-demand, in response to a query, based on alerts or alarms,and/or the like.

In some embodiments, clinical risk alerts are provided that includealert conditions that combine intelligent and dynamic estimativealgorithms that estimate present or predicted danger with greateraccuracy, more timeliness in pending danger, avoidance of false alarms,and less annoyance for the patient. In general, clinical risk alertsinclude dynamic and intelligent estimative algorithms based on analytevalue, rate of change, acceleration, clinical risk, statisticalprobabilities, known physiological constraints, and/or individualphysiological patterns, thereby providing more appropriate, clinicallysafe, and patient-friendly alarms. Co-pending U.S. Patent PublicationNo. 2007/0208246, which is incorporated herein by reference in itsentirety, describes some systems and methods associated with theclinical risk alerts (or alarms) described herein. In some embodiments,clinical risk alerts can be triggered for a predetermined time period toallow for the user to attend to his/her condition. Additionally, theclinical risk alerts can be de-activated when leaving a clinical riskzone so as not to annoy the patient by repeated clinical alarms (e.g.,visual, audible or vibratory), when the patient's condition isimproving. In some embodiments, dynamic and intelligent estimationdetermines a possibility of the patient avoiding clinical risk, based onthe analyte concentration, the rate of change, and other aspects of thedynamic and intelligent estimative algorithms. If there is minimal or nopossibility of avoiding the clinical risk, a clinical risk alert will betriggered. However, if there is a possibility of avoiding the clinicalrisk, the system is configured to wait a predetermined amount of timeand re-analyze the possibility of avoiding the clinical risk. In someembodiments, when there is a possibility of avoiding the clinical risk,the system is further configured to provide targets, therapyrecommendations, or other information that can aid the patient inproactively avoiding the clinical risk.

In some embodiments, the sensor electronics module is configured tosearch for one or more display devices within communication range of thesensor electronics module and to wirelessly communicate sensorinformation (e.g., a data package including displayable sensorinformation, one or more alarm conditions, and/or other alarminformation) thereto. Accordingly, the display device is configured todisplay at least some of the sensor information and/or alarm the host(and/or care taker), wherein the alarm mechanism is located on thedisplay device.

In some embodiments, the sensor electronics module is configured toprovide one or a plurality of different alarms via the sensorelectronics module and/or via transmission of a data packagingindicating an alarm should be initiated by one or a plurality of displaydevices (e.g., sequentially and/or simultaneously). In some embodiments,the sensor electronics module determines which of the one or more alarmsto trigger based on one or more alerts that are triggered. For example,when an alert triggers that indicates severe hypoglycemia, the sensorelectronics module can perform multiple actions, such as activating analarm on the sensor electronics module, transmitting a data package to asmall (key fob) indicating activation of an alarm on the display, andtransmitting a data package as a text message to a care provider. As anexample, a text message can appear on a small (key fob) display, cellphone, pager device, and/or the like, including displayable sensorinformation that indicates the host's condition (e.g., “severehypoglycemia”).

In some embodiments, the sensor electronics module is configured to waita time period for the host to respond to a triggered alert (e.g., bypressing or selecting a snooze and/or off function and/or button on thesensor electronics module and/or a display device), after whichadditional alerts are triggered (e.g., in an escalating manner) untilone or more alerts are responded to. In some embodiments, the sensorelectronics module is configured to send control signals (e.g., a stopsignal) to a medical device associated with an alarm condition (e.g.,hypoglycemia), such as an insulin pump, wherein the stop alert triggersa stop of insulin delivery via the pump.

In some embodiments, the sensor electronics module is configured todirectly, systematically, simultaneously (e.g., via broadcasting),regularly, periodically, randomly, on-demand, in response to a query(from the display device), based on alerts or alarms, and/or the liketransmit alarm information. In some embodiments, the system furtherincludes a repeater such that the wireless communication distance of thesensor electronics module can be increased, for example, to 10, 20, 30,50 75, 100, 150, or 200 meters or more, wherein the repeater isconfigured to repeat a wireless communication from the sensorelectronics module to the display device located remotely from thesensor electronics module. A repeater can be useful to families havingchildren with diabetes. For example, to allow a parent to carry, orplace in a stationary position, a display device, such as in a largehouse wherein the parents sleep at a distance from the child.

Display Devices

In some embodiments, the sensor electronics module is configured tosearch for and/or attempt wireless communication with a display devicefrom a list of display devices. In some embodiments, the sensorelectronics module is configured to search for and/or attempt wirelesscommunication with a list of display devices in a predetermined and/orprogrammable order (e.g., grading and/or escalating), for example,wherein a failed attempt at communication with and/or alarming with afirst display device triggers an attempt at communication with and/oralarming with a second display device, and so on. In one exemplaryembodiment, the sensor electronics module is configured to search forand attempt to alarm a host or care provider sequentially using a listof display devices, such as: 1) a default display device, 2) a key fobdevice, 3) a cell phone (via auditory and/or visual methods, such as,text message to the host and/or care provider, voice message to the hostand/or care provider, and/or 911).

Depending on the embodiment, one or more display devices that receivedata packages from the sensor electronics module are “dummy displays”,wherein they display the displayable sensor information received fromthe sensor electronics module without additional processing (e.g.,prospective algorithmic processing necessary for real-time display ofsensor information). In some embodiments, the displayable sensorinformation comprises transformed sensor data that does not requireprocessing by the display device prior to display of the displayablesensor information. Some display devices may comprise software includingdisplay instructions (software programming comprising instructionsconfigured to display the displayable sensor information and optionallyquery the sensor electronics module to obtain the displayable sensorinformation) configured to enable display of the displayable sensorinformation thereon. In some embodiments, the display device isprogrammed with the display instructions at the manufacturer and caninclude security and/or authentication to avoid plagiarism of thedisplay device. In some embodiments, a display device is configured todisplay the displayable sensor information via a downloadable program(for example, a downloadable Java Script via the internet), such thatany display device that supports downloading of a program (for example,any display device that supports Java applets) therefore can beconfigured to display displayable sensor information (e.g., mobilephones, PDAs, PCs and the like).

In some embodiments, certain display devices may be in direct wirelesscommunication with the sensor electronics module, however intermediatenetwork hardware, firmware, and/or software can be included within thedirect wireless communication. In some embodiments, a repeater (e.g., aBluetooth repeater) can be used to re-transmit the transmitteddisplayable sensor information to a location farther away than theimmediate range of the telemetry module of the sensor electronicsmodule, wherein the repeater enables direct wireless communication whensubstantive processing of the displayable sensor information does notoccur. In some embodiments, a receiver (e.g., Bluetooth receiver) can beused to re-transmit the transmitted displayable sensor information,possibly in a different format, such as in a text message onto a TVscreen, wherein the receiver enables direct wireless communication whensubstantive processing of the sensor information does not occur. In oneembodiment, the sensor electronics module directly wirelessly transmitsdisplayable sensor information to one or a plurality of display devices,such that the displayable sensor information transmitted from the sensorelectronics module is received by the display device withoutintermediate processing of the displayable sensor information.

In one embodiment, one or more display devices comprise built-inauthentication mechanisms, wherein authentication is required forcommunication between the sensor electronics module and the displaydevice. In some embodiments, to authenticate the data communicationbetween the sensor electronics module and display devices, achallenge-response protocol, such as a password authentication isprovided, where the challenge is a request for the password and thevalid response is the correct password, such that pairing of the sensorelectronics module with the display devices can be accomplished by theuser and/or manufacturer via the password. However, any knownauthentication system or method useful for telemetry devices can be usedwith the preferred embodiments.

In some embodiments, one or more display devices are configured to querythe sensor electronics module for displayable sensor information,wherein the display device acts as a master device requesting sensorinformation from the sensor electronics module (e.g., a slave device)on-demand, for example, in response to a query. In some embodiments, thesensor electronics module is configured for periodic, systematic,regular, and/or periodic transmission of sensor information to one ormore display devices (for example, every 1, 2, 5, or 10 minutes ormore). In some embodiments, the sensor electronics module is configuredto transmit data packages associated with a triggered alert (e.g.,triggered by one or more alert conditions). However, any combination ofthe above described statuses of data transmission can be implementedwith any combination of paired sensor electronics module and displaydevice(s). For example, one or more display devices can be configuredfor querying the sensor electronics module database and for receivingalarm information triggered by one or more alarm conditions being met.Additionally, the sensor electronics module can be configured forperiodic transmission of sensor information to one or more displaydevices (the same or different display devices as described in theprevious example), whereby a system can include display devices thatfunction differently with regard to how they obtain sensor information.

In some embodiments, as described in more detail elsewhere herein, adisplay device is configured to query the data storage memory in thesensor electronics module for certain types of data content, includingdirect queries into a database in the sensor electronics module's memoryand/or requests for configured or configurable packages of data contenttherefrom; namely, the data stored in the sensor electronics module isconfigurable, queryable, predetermined, and/or pre-packaged, based onthe display device with which the sensor electronics module iscommunicating. In some additional or alternative embodiments, the sensorelectronics module generates the displayable sensor information based onits knowledge of which display device is to receive a particulartransmission. Additionally, some display devices are capable ofobtaining calibration information and wirelessly transmitting thecalibration information to the sensor electronics module, such asthrough manual entry of the calibration information, automatic deliveryof the calibration information, and/or an integral reference analytemonitor incorporated into the display device. U.S. Patent PublicationNos. 2006/0222566, 2007/0203966, 2007/0208245, and 2005/0154271, all ofwhich are incorporated herein by reference in their entirety, describesystems and methods for providing an integral reference analyte monitorincorporated into a display device and/or other calibration methods thatcan be implemented with the preferred embodiments.

In general, a plurality of display devices (e.g., a small (key fob)display device, a larger (hand-held) display device, a mobile phone, areference analyte monitor, a drug delivery device, a medical device anda personal computer) are configured to wirelessly communicate with thesensor electronics module, wherein the one or more display devices areconfigured to display at least some of the displayable sensorinformation wirelessly communicated from the sensor electronics module,wherein displayable sensor information includes sensor data, such as rawdata and/or transformed sensor data, such as analyte concentrationvalues, rate of change information, trend information, alertinformation, sensor diagnostic information and/or calibrationinformation, for example.

Small (Key Fob) Display Device

In some embodiments, one the plurality of display devices is a small(e.g., key fob) display device 14 (FIG. 1) that is configured to displayat least some of the sensor information, such as an analyteconcentration value and a trend arrow. In general, a key fob device is asmall hardware device with a built-in authentication mechanism sized tofit on a key chain. However, any small display device 14 can beconfigured with the functionality as described herein with reference tothe key fob device 14, including a wrist band, a hang tag, a belt, anecklace, a pendent, a piece of jewelry, an adhesive patch, a pager, anidentification (ID) card, and the like, all of which are included by thephrase “small display device” and/or “key fob device” herein.

In general, the key fob device 14 includes electronics configured toreceive and display displayable sensor information (and optionallyconfigured to query the sensor electronics module for the displayablesensor information). In one embodiment, the electronics include a RAMand a program storage memory configured at least to display the sensordata received from the sensor electronics module. In some embodiments,the key fob device 14 includes an alarm configured to warn a host of atriggered alert (e.g., audio, visual and/or vibratory). In someembodiments, the key fob device 14 includes a user interface, such as anLCD 602 and one or more buttons 604 that allows a user to view data,such as a numeric value and/or an arrow, to toggle through one or morescreens, to select or define one or more user parameters, to respond to(e.g., silence, snooze, turn off) an alert, and/or the like.

In some embodiments, the key fob display device has a memory (e.g., suchas in a gig stick or thumb drive) that stores sensor, drug (e.g.,insulin) and other medical information, enabling a memory stick-typefunction that allows data transfer from the sensor electronics module toanother device (e.g., a PC) and/or as a data back-up location for thesensor electronics module memory (e.g., data storage memory). In someembodiments, the key fob display device is configured to beautomatically readable by a network system upon entry into a hospital orother medical complex.

In some embodiments, the key fob display device includes a physicalconnector, such as USB port 606, to enable connection to a port (e.g.,USB) on a computer, enabling the key fob to function as a data downloaddevice (e.g., from the sensor electronics module to a PC), a telemetryconnector (e.g., Bluetooth adapter/connector for a PC), and/or enablesconfigurable settings on the key fob device (e.g., via software on thePC that allows configurable parameters such as numbers, arrows, trend,alarms, font, etc.) In some embodiments, user parameters associated withthe small (key fob) display device can be programmed into (and/ormodified) by a display device such as a personal computer, personaldigital assistant, or the like. In one embodiment, user parametersinclude contact information, alert/alarms settings (e.g., thresholds,sounds, volume, and/or the like), calibration information, font size,display preferences, defaults (e.g., screens), and/or the like.Alternatively, the small (key fob) display device can be configured fordirect programming of user parameters. In some embodiments, wherein thesmall (key fob) display device comprises a telemetry module, such asBluetooth, and a USB connector (or the like), such that the small (keyfob) display device additionally functions as telemetry adapter (e.g.,Bluetooth adapter) enabling direct wireless communication between thesensor electronics module and the PC, for example, wherein the PC doesnot include the appropriate telemetry adapter therein.

Large (Hand-held) Display Device

In some embodiments, one the plurality of display devices is a hand-helddisplay device 16 (FIG. 1) configured to display sensor informationincluding an analyte concentration and a graphical representation of theanalyte concentration over time. In general, the hand-held displaydevice comprises a display 608 sufficiently large to display a graphicalrepresentation 612 of the sensor data over a time period, such as aprevious 1, 3, 5, 6, 9, 12, 18, or 24-hours of sensor data. In someembodiments, the hand-held device 16 is configured to display a trendgraph or other graphical representation, a numeric value, an arrow,and/or to alarm the host. U.S. Patent Publication No. 2005/0203360,which is incorporated herein by reference in its entirety, describes andillustrates some examples of display of data on a hand-held displaydevice. Although FIG. 6 illustrates one embodiment of a hand-helddisplay device, the hand-held device can be any single applicationdevice or multi-application device, such as mobile phone, a palm-topcomputer, a PDA, portable media player (e.g., iPod, MP3 player), a bloodglucose meter, an insulin pump, and/or the like.

In some embodiments, a mobile phone (or PDA) is configured to display(as described above) and/or relay sensor information, such as via avoice or text message to the host and/or the host's care provider. Insome embodiments, the mobile phone further comprises an alarm configuredto warn a host of a triggered alert, such as in response to receiving adata package indicating triggering of the alert. Depending on theembodiment, the data package may include displayable sensor information,such as an on-screen message, text message, and/or pre-generatedgraphical representation of sensor data and/or transformed sensor data,as well as an indication of an alarm, such as an auditory alarm or avibratory alarm, that should be activated by the mobile phone.

In some embodiments, one of the display devices is a drug deliverydevice, such as an insulin pump and/or insulin pen, configured todisplay sensor information. In some embodiments, the sensor electronicsmodule is configured to wirelessly communicate sensor diagnosticinformation to the drug delivery device in order to enable to the drugdelivery device to consider (include in its calculations/algorithms) aquality, reliability and/or accuracy of sensor information for closedloop and/or semi-closed loop systems, which are described in more detailin U.S. Patent Publication No. 2005/0192557, which is incorporatedherein by reference in its entirety. In some alternative embodiments,the sensor electronic module is configured to wirelessly communicatewith a drug delivery device that does not include a display, forexample, in order to enable a closed loop and/or semi-closed loop systemas described above.

In some embodiments, one of the display devices is a drug deliverydevice is a reference analyte monitor, such as a blood glucose meter,configured to measure a reference analyte value associated with ananalyte concentration in a biological sample from the host.

Personal Computer Display Device

In some embodiments, one of the display devices is personal computer(PC) 20 (FIG. 1) configured to display sensor information. Preferably,the PC 24 has software installed, wherein the software enables displayand/or performs data analysis (retrospective processing) of the historicsensor information. In some embodiments, a hardware device can beprovided (not shown), wherein the hardware device (e.g., dongle/adapter)is configured to plug into a port on the PC to enable wirelesscommunication between the sensor electronics module and the PC. In someembodiments, the PC 24 is configured to set and/or modify configurableparameters of the sensor electronics module 12 and/or small (key fobdevice) 14, as described in more detail elsewhere herein.

Other Display Devices

In some embodiments, one of the display devices is an on-skin displaydevice that is splittable from, releasably attached to, and/or dockableto the sensor housing (mounting unit, sensor pod, or the like). In someembodiments, release of the on-skin display turns the sensor off; inother embodiments, the sensor housing comprises sufficient sensorelectronics to maintain sensor operation even when the on-skin displayis released from the sensor housing.

In some embodiments, one of the display devices is a secondary device,such as a heart rate monitor, a pedometer, a temperature sensor, a carinitialization device (e.g., configured to allow or disallow the car tostart and/or drive in response to at least some of the sensorinformation wirelessly communicated from the sensor electronics module(e.g., glucose value above a predetermined threshold)). In somealternative embodiments, one of the display devices is designed for analternative function device (e.g., a caller id device), wherein thesystem is configured to communicate with and/or translate displayablesensor information to a custom protocol of the alternative device suchthat displayable sensor information can be displayed on the alternativefunction device (display of caller id device).

Exemplary Configurations

FIG. 1 is a diagram illustrating one embodiment of a continuous analytesensor system 8 including a sensor electronics module 12. In theembodiment of FIG. 1, the system includes a continuous analyte sensor 10physically connected to a sensor electronics module 12, which is indirect wireless communication with a plurality of different displaydevices 14, 16, 18, and/or 20.

In one embodiment, the sensor electronics module 12 includes electroniccircuitry associated with measuring and processing the continuousanalyte sensor data, including prospective algorithms associated withprocessing and calibration of the sensor data. The sensor electronicsmodule 12 may be physically connected to the continuous analyte sensor10 and can be integral with (non-releasably attached to) or releasablyattachable to the continuous analyte sensor 10. The sensor electronicsmodule 12 may include hardware, firmware, and/or software that enablesmeasurement of levels of the analyte via a glucose sensor, such as ananalyte sensor. For example, the sensor electronics module 12 caninclude a potentiostat, a power source for providing power to thesensor, other components useful for signal processing and data storage,and preferably a telemetry module for transmitting data from the sensorelectronics module to one or more display devices. Electronics can beaffixed to a printed circuit board (PCB), or the like, and can take avariety of forms. For example, the electronics can take the form of anintegrated circuit (IC), such as an Application-Specific IntegratedCircuit (ASIC), a microcontroller, and/or a processor. The sensorelectronics module 12 includes sensor electronics that are configured toprocess sensor information, such as sensor data, and generatetransformed sensor data and displayable sensor information. Examples ofsystems and methods for processing sensor analyte data are described inmore detail herein and in U.S. Pat. Nos. 7,310,544 and 6,931,327. andU.S. Patent Publication Nos. 2005/0043598, 2007/0032706, 2007/0016381,2008/0033254, 2005/0203360, 2005/0154271, 2005/0192557, 2006/0222566,2007/0203966 and 2007/0208245, all of which are incorporated herein byreference in their entirety.

Referring again to FIG. 1, a plurality of display devices (14, 16, 18,and/or 20) are configured for displaying (and/or alarming) thedisplayable sensor information that has been transmitted by the sensorelectronics module 12 (e.g., in a customized data package that istransmitted to the display devices based on their respectivepreferences). For example, the display devices are configured to displaythe displayable sensor information as it is communicated from the sensorelectronics module (e.g., in a data package that is transmitted torespective display devices), without any additional prospectiveprocessing required for calibration and real-time display of the sensordata.

In the embodiment of FIG. 1, the plurality of display devices includes asmall (key fob) display device 14, such as a wrist watch, a belt, anecklace, a pendent, a piece of jewelry, an adhesive patch, a pager, akey fob, a plastic card (e.g., credit card), an identification (ID)card, and/or the like, wherein the small display device comprises arelatively small display (e.g., smaller than the large display device)and is configured to display certain types of displayable sensorinformation (e.g., a numerical value and an arrow, in some embodiments).In some embodiments, one of the plurality of display devices is a large(hand-held) display device 16, such as a hand-held receiver device, apalm-top computer and/or the like, wherein the large display devicecomprises a relatively larger display (e.g., larger than the smalldisplay device) and is configured to display a graphical representationof the continuous sensor data (e.g., including current and historicdata). Other display devices can include other hand-held devices, suchas a cell phone or PDA 18, an insulin delivery device, a blood glucosemeter, and/or a desktop or laptop computer 24.

Because different display devices provide different user interfaces,content of the data packages (e.g., amount, format, and/or type of datato be displayed, alarms, and the like) can be customized (e.g.,programmed differently by the manufacture and/or by an end user) foreach particular display device. Accordingly, in the embodiment of FIG.1, a plurality of different display devices are in direct wirelesscommunication with the sensor electronics module (e.g., such as anon-skin sensor electronics module 12 that is physically connected to thecontinuous analyte sensor 10) during a sensor session to enable aplurality of different types and/or levels of display and/orfunctionality associated with the displayable sensor information, whichis described in more detail elsewhere herein.

Continuous Sensor

In some embodiments, a glucose sensor comprises a continuous sensor, forexample a subcutaneous, transdermal (e.g., transcutaneous), orintravascular device. In some embodiments, the device can analyze aplurality of intermittent blood samples. The glucose sensor can use anymethod of glucose-measurement, including enzymatic, chemical, physical,electrochemical, spectrophotometric, polarimetric, calorimetric,iontophoretic, radiometric, immunochemical, and the like.

A glucose sensor can use any known method, including invasive, minimallyinvasive, and non-invasive sensing techniques (e.g., fluorescentmonitoring), to provide a data stream indicative of the concentration ofglucose in a host. The data stream is typically a raw data signal, whichis converted into a calibrated and/or filtered data stream that is usedto provide a useful value of glucose to a user, such as a patient or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the wellbeingof the host).

A glucose sensor can be any device capable of measuring theconcentration of glucose. One exemplary embodiment is described below,which utilizes an implantable glucose sensor. However, it should beunderstood that the devices and methods described herein can be appliedto any device capable of detecting a concentration of glucose andproviding an output signal that represents the concentration of glucose.

In one embodiment, the analyte sensor is an implantable glucose sensor,such as described with reference to U.S. Pat. No. 6,001,067 and U.S.Patent Publication No. US-2005-0027463-A1. In another embodiment, theanalyte sensor is a transcutaneous glucose sensor, such as describedwith reference to U.S. Patent Publication No. US-2006-0020187-A1. Instill other embodiments, the sensor is configured to be implanted in ahost vessel or extracorporeally, such as is described in U.S. PatentPublication No. US-2007-0027385-A1, co-pending U.S. Patent applicationSer. No. 11/543,396 filed Oct. 4, 2006, co-pending U.S. patentapplication Ser. No. 11/691,426 filed on Mar. 26, 2007, and co-pendingU.S. patent application Ser. No. 11/675,063 filed on Feb. 14, 2007. Inone alternative embodiment, the continuous glucose sensor comprises atranscutaneous sensor such as described in U.S. Pat. No. 6,565,509 toSay et al., for example. In another alternative embodiment, thecontinuous glucose sensor comprises a subcutaneous sensor such asdescribed with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al.or U.S. Pat. No. 6,484,046 to Say et al., for example. In anotheralternative embodiment, the continuous glucose sensor comprises arefillable subcutaneous sensor such as described with reference to U.S.Pat. No. 6,512,939 to Colvin et al., for example. In another alternativeembodiment, the continuous glucose sensor comprises an intravascularsensor such as described with reference to U.S. Pat. No. 6,477,395 toSchulman et al., for example. In another alternative embodiment, thecontinuous glucose sensor comprises an intravascular sensor such asdescribed with reference to U.S. Pat. No. 6,424,847 to Mastrototaro etal., for example.

Sensor Electronics Module

FIG. 2 is a block diagram illustrating one embodiment of the sensorelectronics module 12 (FIG. 1). In the embodiment of FIG. 2, the sensorelectronics module 12 comprises an application-specific integratedcircuit (ASIC) 205 and a user interface 122. In this embodiment, theASIC 205 is coupled to a communication port 238 and a battery 234.Although the illustrated embodiment shows an Application SpecificIntegrated Circuit (ASIC) 205 that includes much of the electroniccircuitry, the ASIC 205 may be replaced with one or more of any suitablelogic device, such as field programmable gate arrays (FPGA),microprocessors, analog circuitry, or other digital and/or analogcircuitry.

In this embodiment, a potentiostat 210 is coupled to a glucose sensorvia data line 212, for example, in order to receive sensor data from theglucose sensor. In one embodiment, the potentiostat 210 provides avoltage to the glucose sensor via the data line 22 in order to bias thesensor to enable measurement of a current value indicative of theanalyte concentration in the host (also referred to as the analogportion). The potentiostat can have one channel or multiple channels(and a corresponding one or multiple data lines 212), depending on thenumber of working electrodes, for example. In some embodiments, thepotentiostat 210 includes a resistor (not shown) that translates thecurrent into voltage. In some embodiments, a current to frequencyconverter is provided that is configured to continuously integrate themeasured current, for example, using a charge counting device. In someembodiments, an A/D converter digitizes the analog signal into “counts”for processing. Accordingly, the resulting raw data stream in counts isdirectly related to the current measured by the potentiostat 210.

A processor module 214 is the central control unit that controls theprocessing of the sensor electronics module 12. In some embodiments, theprocessor module 214 is formed as part of a custom chip, such as anASIC, however a computer system other than an ASIC can be used toprocess data as described herein, for example a microprocessor can beused for some or all of the sensor electronics module processing. Theprocessor module 214 typically provides a program memory 216, whichprovides semi-permanent storage of data, for example, storing data suchas sensor identifier (ID) and programming to process data streams (forexample, filtering, calibration, fail-safe checking, and the like). Theprocessor additionally can be used for the system's cache memory, forexample for temporarily storing recent sensor data. In some embodiments,the processor module comprises memory storage components such as ROM,RAM, dynamic-RAM, static-RAM, non-static RAM, EEPROM, rewritable ROMs,flash memory, and the like. In one exemplary embodiment, RAM 218 can beused for the system's cache memory, for example for temporarily storingrecent sensor data.

In some embodiments, the processor module 214 comprises a digitalfilter, for example, an IIR or FIR filter, configured to smooth the rawdata stream from the A/D converter. Generally, digital filters areprogrammed to filter data sampled at a predetermined time interval (alsoreferred to as a sample rate). In some embodiments, such as when thepotentiostat 210 is configured to measure the analyte at discrete timeintervals, these time intervals determine the sample rate of the digitalfilter. In some alternative embodiments, wherein the potentiostat 210 isconfigured to continuously measure the analyte, for example, using acurrent-to-frequency converter, the processor module 214 can beprogrammed to request a digital value from the integrator at apredetermined time interval, also referred to as the acquisition time.In these alternative embodiments, the values obtained by the processormodule 214 are advantageously averaged over the acquisition time due thecontinuity of the current measurement. Accordingly, the acquisition timedetermines the sample rate of the digital filter.

In an advantageous embodiment, the processor module 214 may be furtherconfigured to generate data packages for transmission to one or moredisplay devices. Furthermore, the processor module 215 may generate datapackets for transmission to these outside sources, e.g., via telemetry.As discussed above, the data packages may be customizable for eachdisplay device, for example, and may include any available data, such asdisplayable sensor information having customized sensor data and/ortransformed sensor data, sensor/sensor electronics module ID code, rawdata, filtered data, calibrated data, rate of change information, trendinformation, error detection or correction, and/or the like.

A data storage memory 220 is operably connected to the processor module214 and is configured to store a variety of sensor information. In someembodiments, the data storage memory stores 1, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, 15, 20, 30 or more days of continuous analyte sensordata. In some embodiments, the data storage memory 220 stores sensorinformation such as raw sensor data (one or more raw analyteconcentration values), calibrated data, filtered data, transformedsensor data, and/or any other displayable sensor information.

In some embodiments, sensor electronics module 12 is configured toreceive and store contact information in the data storage memory (and/orprogram memory), including a phone number and/or email address for thesensor's host and/or health care providers for the host (e.g., familymember(s), nurse(s), doctor(s), or other health care provider(s)), whichenables communication with a contact person (e.g., via phone, pagerand/or text messaging in response to an alarm (e.g., a hypoglycemicalarm that has not been responded to by the host)). In some embodiments,user parameters can be programmed into (and/or modified in) the datastorage memory (and/or program memory) of the sensor electronics module,via a display device such as a personal computer, personal digitalassistant, or the like. Preferably, user parameters include contactinformation, alert/alarms settings (e.g., thresholds, sounds, volume,and/or the like), calibration information, font size, displaypreferences, defaults (e.g., screens), and/or the like. Alternatively,the sensor electronics module can be configured for direct programmingof certain user parameters.

In one embodiment, clinical data of a medical practitioner may beuploaded to the sensor electronics module 12 and stored on the datastorage memory 220, for example. Thus, information regarding the host'scondition, treatments, medications, etc., may be stored on the sensorelectronics module 12 and may be viewable by the host or otherauthorized user. In one embodiment, certain of the clinical data may beincluded in a data package that is transmitted to a display device inresponse to triggering of an alert. The clinical data may be uploaded tothe sensor electronics module 12 via any available communicationprotocol, such as direct transmission via a wireless Bluetooth,infrared, or RF connection, or via a wired USB connection, for example.Additionally, the clinical data may be uploaded to the sensorelectronics module 12 via indirect transmission, such as via one or morenetworks (e.g., local area, personal area, or wide area networks, or theInternet) or via a repeater device that receives the clinical data froma device of the medical practitioner and retransmits the clinical datato the sensor electronics module.

Although separate data storage and program memories are shown in FIG. 1,one skilled in the art appreciates a variety of configurations,including one or multiple memories that provide the necessary storagespace to support the sensor electronic module 12 data processing andstorage requirements. Accordingly, the described location of storage ofany particular information and/or or programming is not meant to belimiting, but rather exemplary.

In some embodiments, the sensor electronics module 12 is configured toperform smoothing and/or filtering algorithms on the sensor data (e.g.,raw data stream and/or other sensor information), wherein the smoothedand/or filtered data is stored in the data storage memory as transformeddata. Co-pending U.S. Patent Publication Nos. 2005/0043598,2007/0032706, 2007/0016381 and 2008/0033254 describe some algorithmsuseful in performing data smoothing and/or filtering herein (includingsignal artifacts replacement), and are incorporated herein by referencein their entirety.

In some embodiments, the sensor electronics module 12 is configured tocalibrate the sensor data, and the data storage memory 220 stores thecalibrated sensor data points as transformed sensor data. In somefurther embodiments, the sensor electronics module 12 is configured towirelessly receive calibration information from a display device, fromwhich the sensor electronics module is configured to calibrate thesensor data. U.S. Pat. Nos. 7,310,544 and 6,931,327 describe somealgorithms useful in sensor calibration herein, and are incorporatedherein by reference in their entirety.

In some embodiments, the sensor electronics module 12 is configured toperform additional algorithmic processing on the sensor data (e.g.,calibrated and/or filtered data and/or other sensor information) and thedata storage memory 220 is configured to store the transformed sensordata and/or sensor diagnostic information associated with thealgorithms. U.S. Pat. Nos. 7,310,544 and 6,931,327 describe somealgorithms that can be processed by the sensor electronics module, andare incorporated herein by reference in their entirety.

Referring again to FIG. 5, a user interface 222 can include a variety ofinterfaces, such as one or more buttons 224, a liquid crystal display(LCD) 226, a vibrator 228, an audio transducer (e.g., speaker) 230,backlight, and/or the like. A backlight can be provided, for example, toaid the user in reading the LCD in low light conditions. The componentsthat comprise the user interface 222 provide controls to interact withthe user (e.g., the host). One or more buttons 224 can allow, forexample, toggle, menu selection, option selection, status selection,yes/no response to on-screen questions, a “turn off” function (e.g., foran alarm), a “snooze” function (e.g., for an alarm), a reset, and/or thelike. The LCD 226 can be provided, for example, to provide the user withvisual data output. The audio transducer 230 (e.g., speaker) providesaudible signals in response to triggering of certain alerts, such aspresent and/or predicted hyper- and hypoglycemic conditions. In someembodiments, audible signals are differentiated by tone, volume, dutycycle, pattern, duration, and/or the like. In some embodiments, theaudible signal is configured to be silenced (e.g., snoozed or turnedoff) by pressing one or more buttons 224 on the sensor electronicsmodule and/or by signaling the sensor electronics module using a buttonor selection on a display device (e.g., key fob, cell phone, and/or thelike).

In some embodiments, the audio transducer 230 is mounted to the circuitboard and/or the sensor electronics module housing. In some embodiments,the sound produced by the audio transducer 230 exits the device from asound port in the sensor electronics module 12, such as a hole on thesensor electronics module body 12. Preferably, the hole is waterproofedand/or otherwise protected from moisture by a waterproof material thateasily allows sound waves there through. In one preferred embodiment,the hole is protected from moisture by an acoustically transparentventing material (wherein the material allows at least about 60%, 70%,80%, 90%, 95%, or more of the transmitted sound waves there through),such as a screw-in vent, a press-fit vent, a snap-in vent, an o-ringvent, and adhesive vent, and/or the like. One manufacturer that providesacoustically transparent venting material is W.L. Gore & Associates(Elkton, Md.) under the trade name Protective Vents (Acoustic Vents).

The vibrator 228 can include a motor that provides, for example, tactilesignals or alerts for reasons such as described with reference to theaudio transducer, above. In one embodiment, the vibrator motor 228provides a signal in response to triggering of one or more alerts, whichcan be triggered by the processor module 214 that processes algorithmsuseful in determining whether alert conditions associated with one ormore alerts have been met, for example, present and/or predicted hyper-and hypoglycemic conditions. In some embodiments, one or more differentalerts are differentiated by intensity, quantity, pattern, duration,and/or the like. In some embodiments, the alarm is configured to besilenced (e.g., snoozed or turned off) by pressing one or more buttons224 on the sensor electronics module 12 and/or by signaling the sensorelectronics module 12 using a button or selection on a display device(e.g., key fob, cell phone, and/or the like).

In some embodiments, the vibrator motor 228 is mounted to the circuitboard and/or the sensor electronics module 12 housing. Preferably thediameter of the motor is less than or equal to about 6 mm, 5 mm, 4 mm,3.5 mm, 3 mm, 2.5 mm, 2 mm or less. Preferably the overall length of thevibrator motor is less than or equal to about 18 mm, 16 mm, 14 mm, 12mm, 10 mm or less. By providing a low power vibrator motor, the motorcan be place in the sensor electronics module 12 without significantlyaffecting the low profile nature of the on-skin sensor electronicsmodule 12.

In some embodiments, the vibrator motor 228 may be used to provide avibratory alarm that creates vibration and/or movement of the sensorwithin the host. While not wishing to be bound by theory, it is believedthat a concentration increase of noise-causing electroactive species,such as electroactive metabolites from cellular metabolism and woundhealing, can interfere with sensor function and cause noise observedduring host start-up and/or sedentary periods. For example, local lymphpooling, which can occur when a part of the body is compressed or whenthe body is inactive, can cause, in part, this local build up ofinterferants (e.g., electroactive metabolites). Similarly, a localaccumulation of wound healing metabolic products (e.g., at the site ofsensor insertion) likely causes noise on the sensor during the first fewhours to days after sensor insertion. Accordingly, it is believedvibration and/or movement of the sensor at the insertion site, aftersensor insertion, can reduce or eliminate pooling of local interferingspecies caused by the wound healing process described above. In someembodiments, the sensor is vibrated and/or moved at predeterminedintervals and/or in response to noise artifacts detected on the sensorsignal. Co-pending U.S. Patent Application No. 2005/0043598,2007/0032706, 2007/0016381 or 2008/0033254 describe systems and methodsfor detection of noise artifacts, noise episodes and/or classificationof noise, which can be useful with the embodiments described herein.

Although audio and vibratory alarms are exemplified in FIG. 5,alternative alarming mechanisms can be used in some embodiments. Forexample, in one alternative embodiment, a tactile alarm is providedincluding a poking mechanism (not shown) configured to “poke” thepatient in response to one or more alarm conditions.

In another alternative embodiment, the sensor electronics module 12 isconfigured to transmit sound waves into the host's body (e.g., abdomenor other body part) that will be felt by the host, thereby allowing thehost to be alerted without calling attention to himself and/or therebyallowing a hearing-impaired visually-impaired, and/or tactilely-impairedhost to be alerted. In some embodiments, the sound waves can betransmitted into the host's body using the electrodes of the sensoritself. In some embodiments, one or more transcutaneous electrodes(other than the electrodes related to analyte measurement) are providedfor transmitting sound waves. In some embodiments, electrodes can beprovided in the adhesive patch that holds the sensor/sensor electronicsmodule onto the host's body, which can be used to transmit the soundwaves. In some embodiments, different sound waves are used to transmitdifferent alarm conditions to the host. The sound waves could bedifferentiated by any sound characteristic, such as but not limited toamplitude, frequency and pattern.

In another alternative embodiment, mild electric shock could be used totransmit one or more alarms to the host. Preferably the level of shockwould not be overly uncomfortable to the host; however, the intensity ofthe level of shock can be configured to increase when a host does notrespond to (e.g., snooze or turn off) an alert within an amount of time.In some embodiments, the shock can be delivered to the host's body usingthe electrodes of the sensor itself. In some embodiments, the sensorsystem can include one or more additional electrodes configured fordelivering the shock to the host (alone or in combination with theelectrodes related to analyte measurement). In still another example,the one or more electrodes can be disposed on the host's skin, such asin the adhesive patch, for delivering the shock. Alternatively, one ormore additional patches, each including an electrode, can be provided,for delivering the shock. The additional patches can be in wired and/orwireless communication with the sensor electronics module.

A telemetry module 232 is operably connected to the processor module 214and provides the hardware, firmware, and/or software that enablewireless communication between the sensor electronics module 12 and oneor more display devices. A variety of wireless communicationtechnologies that can be implemented in the telemetry module 232 includeradio frequency (RF), infrared (IR), Bluetooth, spread spectrumcommunication, frequency hopping communication, ZigBee, IEEE802.11/802.16, wireless (e.g., cellular) telecommunication, pagingnetwork communication, magnetic induction, satellite data communication,GPRS, ANT, and/or the like. In one preferred embodiment, the telemetrymodule comprises a Bluetooth chip. In some embodiments, Bluetoothtechnology is implemented in a combination of the telemetry module 232and the processor module 214.

A battery 234 is operatively connected to the processor module 214 (andpossibly other components of the sensor electronics module 12) andprovides the necessary power for the sensor electronics module 12. Inone embodiment, the battery is a Lithium Manganese Dioxide battery,however any appropriately sized and powered battery can be used (e.g.,AAA, Nickel-cadmium, Zinc-carbon, Alkaline, Lithium, Nickel-metalhydride, Lithium-ion, Zinc-air, Zinc-mercury oxide, Silver-zinc, orhermetically-sealed). In some embodiments the battery is rechargeable.In some embodiments, a plurality of batteries can be used to power thesystem. In yet other embodiments, the receiver can be transcutaneouslypowered via an inductive coupling, for example.

A battery charger and/or regulator 236 may be configured to receiveenergy from an internal and/or external charger. In one embodiment, abattery regulator (or balancer) 236 regulates the recharging process bybleeding off excess charge current to allow all cells or batteries inthe sensor electronics module to be fully charged without overchargingother cells or batteries. In some embodiments, the battery 234 (orbatteries) is configured to be charged via an inductive and/or wirelesscharging pad. One skilled in the art appreciates a variety of knownmethods of charging batteries, which can be implemented with the systemdescribed herein, including wired (cable/plug) and wireless methods.

One or more communication ports 238, also referred to as externalconnector(s), can be provided to allow communication with other devices,for example a PC communication (com) port can be provided to enablecommunication with systems that are separate from, or integral with, thesensor electronics module. The communication port, for example, maycomprise a serial (e.g., universal serial bus or “USB”) communicationport, allows for communicating with another computer system (e.g., PC,personal digital assistant or “PDA,” server, or the like). In oneexemplary embodiment, the sensor electronics module 12 is able totransmit historical data to a PC or other computing device forretrospective analysis by a patient and/or physician.

In conventional continuous analyte sensor systems, the on-skin portionof the sensor electronics is generally simplified to minimize complexityand/or size of on-skin electronics, for example, providing only raw,calibrated, and/or filtered data to a secondary display deviceconfigured to run calibration and other algorithms required fordisplaying the sensor data. In contrast, the sensor electronics module12 executes prospective algorithms used to generate transformed sensordata and/or displayable sensor information, including, for example,algorithms that: evaluate a clinical acceptability of reference and/orsensor data, evaluate calibration data for best calibration based oninclusion criteria, evaluate a quality of the calibration, compareestimated analyte values with time corresponding measured analytevalues, analyze a variation of estimated analyte values, evaluate astability of the sensor and/or sensor data, detect signal artifacts(noise), replace signal artifacts, determine a rate of change and/ortrend of the sensor data, perform dynamic and intelligent analyte valueestimation, perform diagnostics on the sensor and/or sensor data, setmodes of operation, evaluate the data for aberrancies, and/or the like,which are described in more detail in U.S. Pat. Nos. 7,310,544 and6,931,327. and U.S. Patent Publication Nos. 2005/0043598, 2007/0032706,2007/0016381, 2008/0033254, 2005/0203360, 2005/0154271, 2005/0192557,2006/0222566, 2007/0203966 and 2007/0208245, all of which areincorporated herein by reference in their entirety. Furthermore, thesensor electronics module 12 is configured to store the transformedsensor data (e.g., values, trend information) and to communicate thedisplayable sensor information to a plurality of different displaydevices. In some embodiments, the display devices are “dummy” devices,namely, they are configured to display the displayable sensorinformation as received from the sensor electronics module 12, withoutany additional sensor data processing.

Exemplary System Configurations

FIG. 3A is a diagram illustrating one embodiment of a sensor electronicsmodule 312 in communication with multiple sensors, including a glucosesensor 320, an altimeter 322, an accelerometer 324, and a temperaturesensor 328. In this embodiment, each of the sensors 320-328 communicatessensor data wirelessly to the sensor electronics module 312. In otherembodiments, the sensor electronics module 312 comprises one or more ofthe sensors 320-328. In other embodiments, the sensors are combined inany other configuration, such as a combined glucose/temperature sensorthat transmits sensor data to the sensor electronics module 312 usingcommon communication circuitry. Depending on the embodiment, fewer oradditional sensors may communicate with the sensor electronics module312. In other embodiments, one or more of the sensors 320-328 isdirectly coupled to the sensor electronics module 312, such as via oneor more electrical communication wires.

In the embodiment of FIG. 3A, the sensor electronics module 312generates and transmits a data package to display device 350, which maybe any electronic device that is configured to receive, store,retransmit, and/or display displayable sensor data. Advantageously, thesensor electronics module 312 analyzes the sensor data from the multiplesensors and determines which displayable sensor data is to betransmitted to the particular display device 350, based on one or moreof many characteristics of the host, the display device 350, a user ofthe display device 350, and characteristics of the sensor data and/orthe transformed sensor data. Thus, the customized displayable sensorinformation that is transmitted to the display device 350 may bedisplayed on the display device with minimal processing by the displaydevice 350.

FIGS. 3B and 3C are perspective and side views of a sensor systemincluding a mounting unit 314 and sensor electronics module 12 attachedthereto in one embodiment, shown in its functional position, including amounting unit and a sensor electronics module matingly engaged therein.In some preferred embodiments, the mounting unit 314, also referred toas a housing or sensor pod, comprises a base 334 adapted for fasteningto a host's skin. The base can be formed from a variety of hard or softmaterials, and preferably comprises a low profile for minimizingprotrusion of the device from the host during use. In some embodiments,the base 334 is formed at least partially from a flexible material,which is believed to provide numerous advantages over conventionaltranscutaneous sensors, which, unfortunately, can suffer frommotion-related artifacts associated with the host's movement when thehost is using the device. Preferably, the mounting unit 314 and/orsensor electronics module 12 is/are located over the sensor insertionsite to protect the site and/or provide a minimal footprint (utilizationof surface area of the host's skin).

In some embodiments, a detachable connection between the mounting unit314 and sensor electronics module 12 is provided, which enables improvedmanufacturability, namely, the relatively inexpensive mounting unit 314can be disposed of when replacing the sensor system after its usablelife, while the relatively more expensive sensor electronics module 12can be reusable with multiple sensor systems. In some preferredembodiments, the sensor electronics module 12 is configured with signalprocessing (programming), for example, configured to filter, calibrateand/or other algorithms useful for calibration and/or display of sensorinformation. However, an integral (non-detachable) sensor electronicsmodule can be configured.

In some embodiments, the contacts 338 are mounted on or in a subassemblyhereinafter referred to as a contact subassembly 336 configured to fitwithin the base 334 of the mounting unit 314 and a hinge 348 that allowsthe contact subassembly 336 to pivot between a first position (forinsertion) and a second position (for use) relative to the mounting unit314. The term “hinge” as used herein is a broad term and is used in itsordinary sense, including, without limitation, to refer to any of avariety of pivoting, articulating, and/or hinging mechanisms, such as anadhesive hinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In preferred embodiments, the contacts 338 are formed from aconductive elastomeric material, such as a carbon black elastomer,through which the sensor 10 extends.

In certain embodiments, the mounting unit 314 is provided with anadhesive pad 308, preferably disposed on the mounting unit's backsurface and preferably including a releasable backing layer. Thus,removing the backing layer and pressing the base portion 334 of themounting unit onto the host's skin adheres the mounting unit 314 to thehost's skin. Additionally or alternatively, an adhesive pad can beplaced over some or all of the sensor system after sensor insertion iscomplete to ensure adhesion, and optionally to ensure an airtight sealor watertight seal around the wound exit-site (or sensor insertion site)(not shown). Appropriate adhesive pads can be chosen and designed tostretch, elongate, conform to, and/or aerate the region (e.g., host'sskin). The embodiments described with reference to FIGS. 3B and 3C aredescribed in more detail with reference to U.S. Pat. No. 7,310,544,which is incorporated herein by reference in its entirety. Preferably,configurations and arrangements that provide water resistant,waterproof, and/or hermetically sealed properties are providedassociated with the mounting unit/sensor electronics module embodimentsdescribed herein.

FIG. 4 is a diagram illustrating one embodiment of a sensor electronicsmodule 412 in communication with a combined glucose and temperaturesensor 420, as well as an accelerometer 422. In the embodiment of FIG.4, the glucose and temperature sensor 420 senses both a glucose level ofthe host and a temperature of the host, such as a skin temperatureand/or a subcutaneous temperature of the host. In the embodiment of FIG.4, the glucose and temperature sensor 420 are coupled to the sensorelectronics module 412 via a physical connection, such as one or moreelectrical lines. In one embodiment, a housing attached to the glucoseand temperature sensor 420 attaches directly to the sensor electronicsmodule 412. In the embodiment of FIG. 4, an accelerometer 422 is also inwireless communication with the sensor electronics module 412, such asradio frequency, Bluetooth, or ANT communications, for example.

The sensor electronics module 412 is configured to generate and transmitcustomized data packages to each of a plurality of display devices,including display devices 450A, 450B and 450N. As discussed furtherbelow, the timing, content, and formatting of displayable sensorinformation that is included in respective data packages may be based onone or more of a plurality of factors. For example, one or more alertsmay be established based on default alert conditions or custom alertconditions that are designated by the device manufacturer, the host, ora guardian of the host. An alert is said to be “triggered” when thealert conditions associated with the alert are met by the sensor dataand/or transformed sensor data. For example, a near hypoglycemic alertmay include an alert condition that requires that the host's currentglucose level is below 80 mg/dL. Thus, the particular near hypoglycemicalert would be triggered when the host's current glucose level is below80 mg/dL, and, in response to triggering of the alert, any actionsassociated with the particular alert are initiated. In one embodiment,actions associated with an alert may include generation of displayablesensor information, transmission of a data package to one or moredisplay devices, activating one or more alarms (e.g., auditory orvibratory), communicating data to another device, or any other action.For example an action that transmits a customized data package to eachof a plurality of display devices may be associated with a nearhypoglycemic alert. Thus, when the alert conditions for the nearhypoglycemic alert are triggered, the actions initiate compilation andtransmission of the indicated data packages to the respective displaydevices. In one embodiment, the content and formatting of each datapackage may be customized, such that displayable sensor informationincluded in the respective data packages may include quite differentdisplayable sensor information.

In the embodiment of FIG. 4, a first data package 430A is transmitted toa first display device 450A, while a second data package 430B istransmitted to a second display device 450B and a third data package430N is transmitted to a third display device 450N. In this embodiment,each data package 430A, 430B, 430C may be customized for the respectivereceiving display devices. For example, the first data package 430A mayinclude only an indication of a current glucose level of the host, whilethe second data package 430B may include historical sensor data as wellas one or more trend indicators associated with the host's glucoselevels. Additionally, the formatting of the displayable sensor data maybe customized for each receiving display device. For example, each ofdisplay devices 450B and 450N may receive a 20 minute trend indicator inresponse to triggering a near hypoglycemic alert; however, theformatting of the 20 minute trend indicators that are transmitted to thedisplay devices 450B and 450N may be quite different. Thus, the sensorelectronics module 412 allows extensive customization of the timing,content, and delivery parameters for delivering data packages torespective display devices.

FIG. 5A is a diagram illustrating one embodiment of a sensor electronicsmodule 512 directly transmitting data to a first display device 550 andindirectly transmitting sensor data to second and third display devices552, 554 via the Internet 560 and the display device 550. In theembodiment of FIG. 5A, the sensor electronics module 512 comprises atelemetry module that is configured to communicate with the firstdisplay device 550, which in turn, is configured to communicate withmultiple other display devices via the Internet 560. For example, thesensor electronics module 512 may include a Bluetooth transmitter thattransmits data packages, such as in response to triggering of an alert,to the first display device 550, such as a mobile phone. In thisexample, the mobile phone may also include wireless Internetcapabilities, such as might be provided by Wi-Fi or WiMax circuitry,such that the mobile phone can communicate with other devices incommunication with the Internet 560. Accordingly, the sensor electronicsmodule 512 may transmit data packages to a nearby display device 550,along with an indication that the display device 550 should transmit thedata package (or a portion of the displayable sensor information in thedata package) to one or more other display devices (such as displaydevices that are not in close proximity to the sensor electronics module512), via the Internet 560. In this embodiment, displayable sensorinformation is transmitted to remote display devices through the use ofan intermediate display device 550. In other embodiments, the sensorelectronics module 512 is configured to transmit data packages accordingto two or more communication protocols, such as Bluetooth and Wi-Fi. Inthat embodiment, the sensor electronics module 512 may communicate withthe display device 550 via Bluetooth and may communicate with thedisplay devices 552, 554 via the Internet 560 (without the need for thedata to be retransmitted by the display device 550), for example.

In the embodiment of FIG. 5A, a pacemaker 526 is in communication withthe glucose sensor 550. In this embodiment, the pacemaker 526 maytransmit data to the glucose sensor 550 and/or may receive data, such ascontrol signals, from the glucose sensor 550. In this embodiment, theglucose sensor 550 functions as a repeater, transferring control signalsfrom the sensor electronics module 512 to the pacemaker 526, such as inresponse to triggering of an alert based on sensor data from one or moreof the glucose sensor 550, the accelerometer 524, and/or the pacemaker526. In one embodiment, control signals transmitted to the pacemaker 526may indicate changes in operation of the pacemaker 526, such asincreasing or decreasing a frequency of stimulation applied by thepacemaker 526. In another embodiment, the pacemaker 526, or otherdevices such as an insulin pump or a brain scintillator, may be coupleddirectly to the sensor electronics module 512, via a wired and/orwireless communication path. Accordingly, the sensor electronics module512 may receive sensor data from multiple sensors, process the sensordata in order to generate transformed sensor data, determine if anyalert conditions have been satisfied by the sensor data and/or thetransformed sensor data, and perform actions associated with anytriggered alerts, including transmission of control signals to otherdevices, such as the pacemaker 526, and transmission of customized datapackages to one or more display devices.

FIG. 5B is a diagram illustrating one embodiment of the sensorelectronics module 512 configured to transmit control signals tobiological devices coupled to the host. In the embodiment of FIG. 5B,the sensor electronics module 512 receives sensor data from a glucosesensor 550, and possibly other sensors, and transmits control signals toone or more of the insulin pump 560, the pacemaker 570, and/or the brainscintillator 580. Other biological devices that provide medicines and/orstimulations to the host may also be in communication with the sensorelectronics module 512. In the embodiment of FIG. 5B, an exemplarytemporal flow of data is indicated by the circled numerals. In step oneof the exemplary process (indicated by the circled “1” in FIG. 5B), theglucose sensor provides raw sensor data to the sensor electronics module512, such as on a periodic or intermittent basis. In step two, thesensor electronics module 512 processes the sensor data, generates anytransformed sensor data that is required to determine if any alerts havetriggered, and determines if any alerts have triggered based on thereceived sensor data and/or transformed sensor data. In this embodiment,one possible action associated with a triggered alert is to transmitcontrol signals to one or more other biological devices, such as theinsulin pump 560, the brain scintillator 580, and/or the pacemaker 570(e.g., step 3 of FIG. 5B). For example, a hyperglycemic alert may beassociated with an action of transmitting a control signal to theinsulin pump 560 indicating that insulin should be pumped to the host,and possibly details of a dosage and/or time for providing the insulinto the host. Similarly, a low heart rate alert, such as based on datareceived from a heart rate sensor (not shown) may include an action oftransmitting a control signal to the pacemaker 570 indicating that thepacemaker should adjust a timing and/or algorithm at which impulses areadministered to the host. Accordingly, a sensor electronics module 512may receive sensor data from one or more sensors, process the sensordata in order to determine if any alerts are triggered, and performactions associated with triggered alerts that cause control signals tobe transmitted to respective biological devices, such as thoseillustrated in FIG. 5B.

In the embodiment of FIG. 5B, biological devices 560, 570, 580 are eachin communication with the sensor electronics module 512 via a wirelesscommunication link, such as radio frequency, Bluetooth, or ANTcommunications. In other embodiments, one or more of these biologicaldevices may be directly physically coupled to the sensor electronicsmodule, such as via one or more data lines. In another embodiment, oneor more of the biological devices may be integral to a sensor, such asglucose sensor 550, such that control signals from the sensorelectronics module 512 may be transmitted to a integratedsensor/biological device. In yet another embodiment, the sensorelectronics module transmits indications of control signals to anexternal device, such as a display device, which then relays theappropriate control signal to the corresponding biological device. Forexample, the sensor electronics module 512 may transmit an indication ofa control signal to a cellular phone of the host, for example, with anindication that the control signal should be transmitted to a particularbiological device, such as the brain scintillator 580. In oneembodiment, the communication protocol used by the sensor electronicsmodule 512 in communicating with the cellular telephone is differentthan a communication protocol used by the cellular telephone incommunicating with the brain scintillator 580. Accordingly, the sensorelectronics module 512 may communicate with a wider range of biologicaldevices through the use of another device, such as a display device,that receives the control signal indications via a first communicationprotocol (e.g., Bluetooth) and transmits corresponding control signalsto the appropriate biological devices via a second communicationprotocol (e.g., Radio Frequency), which the sensor electronics modulemay not be configured to use.

FIG. 5C is a diagram illustrating one embodiment of the sensorelectronics module 512 in communication with multiple sensors, whereinthe sensor electronics module 512 transmits data packages to multipledisplay devices via multiple networks, such as the Internet 560 and atelephone network 565. In the embodiment of FIG. 5C, the sensorelectronics module 512 is in communication with the Internet 560 as wellas a telephone network 565, which may comprise one or more cellularnetworks, digital or analog wireless telephone networks, or plain oldtelephone service (POTS) networks. Thus, in the embodiment of FIG. 5C,the sensor electronics module 512 may transmit short message service(SMS) messages, for example, to the display device 554. Additionally,the sensor electronics module 512 may transmit other types of messages,such as voice messages, paging signals, or other data packages, via thetelephone network 565. In this embodiment, the sensor electronics module512 is also configured to transmit data packages to the other displaydevices 550, 552 via the Internet 560.

FIG. 6 is a flowchart illustrating one embodiment of a method ofgenerating customizable data packages for delivery to respective displaydevices, such as based on user-defined delivery options. As noted above,the sensor electronics modules discussed herein advantageously allowcustomization of displayable sensor information, such as combinations ofsensor data and/or transformed sensor data, for transmission torespective display devices. Depending on the embodiment, the method ofFIG. 6 may include viewer or additional blocks in the blocks may breedperformed in a different order than is illustrated.

Beginning in block 610, the sensor electronics module intermittentlyreceives and/or processes sensor data from one or more sensors, such asa glucose sensor, accelerometer, altimeter, or any other sensor. Each ofthe sensors that transmit sensor data to the sensor electronics modulemay have a predetermined or dynamic schedule for transmitting sensordata. For example, a first sensor may transmit sensor data to the sensorelectronics module on a consistent periodic basis, such as one sensordata point per minute, 5 minutes, 10 minutes, 30 minutes etc., while asecond sensor may transmit sensor data to the sensor electronics moduleonly when the sensor data reaches a certain threshold. For example, analtimeter may only transmit sensor data to the sensor electronics module512 when an altitude of the altimeter is above a predeterminedthreshold.

Moving to block 620, the sensor data received from the one or moresensors is stored, such as in one or more memories and/or storagedevices of the sensor electronics module. With reference to theembodiment of FIG. 2, the sensor data may be stored in the data storagememory 220 and/or the random access memory 218.

Next, in block 630 the sensor electronics module determines if one ormore alerts have been triggered. As noted above, each alert isassociated alert conditions that must be met in order for the respectivealert to trigger. The alert conditions could be any characteristic ofthe sensor data, transformed sensor data, a display device, a host, oran operator of a display device, along with other characteristics. Forexample, two different alerts that are each related to the host reachinga hypoglycemic glucose level may have slightly different alertconditions that must be satisfied in order to trigger the alerts. Forexample, a first hypoglycemic alert may require that the host's glucoselevel is below a first threshold and that a temperature of the host isabove a certain threshold, while a second hypoglycemic alert may onlyrequire that the host's glucose level is below a second threshold (whichmay be slightly lower than the first threshold). In this embodiment, thefirst and second hypoglycemic alerts may be associated with actions thatare quite different, such as transmission of data packages of variouscontent and formatting to different display devices.

If the sensor electronics module determines that an alert has triggeredin block 630, the method continues to block 640 where one or moreactions associated with the triggered alert are initiated. For an actionthat includes transmission of one or more data packages to a respectiveone or more display devices, each of the data packages may be associatedwith one or more delivery options indicating the content (e.g., whichdisplayable sensor information, such as sensor data and/or transformedsensor data, should be included in the data package) and/or formattingrequirements for the indicated displayable sensor information, such aswhether the displayable sensor information should be in a textual orgraphical format. Other actions might include alarms that are associatedwith the sensor electronics module or a display device, such asactivation of a vibrator motor or audio transducer, for example.

In block 650, the sensor electronics module determines the deliveryoptions associated with the actions of the triggered alert and generatesthe appropriate displayable sensor information in response to thedelivery options. In one embodiment, the sensor electronics moduleperforms algorithmic operations on the sensor data in order to generatetransformed sensor data, such as trending data, which is stored in thesensor electronics module for later access. In other embodiments, thesensor electronics module executes algorithms on the sensor data inresponse to triggering of an alert, such that the transformed sensordata included in the data package is generated after the alert istriggered. Alternatively, the sensor electronics module may generatesome transformed sensor data as the sensor data is received and may alsogenerate additional transformed sensor data in response to triggering ofan alert. In one embodiment, the displayable sensor information isselected according to parameters of the alert action, and thedisplayable sensor information is combined into one or more datapackages for transmission to the display device indicated in the action.

Next, in block 660, the generated data package is transmitted to displaydevice indicated in the alert action. If more than one action isassociated with a triggered alert, multiple data packages may begenerated and transmitted to respective display devices. Accordingly,the sensor electronics module allows customization of alertnotifications including various levels of detail that are desired by thehost or other interested parties.

FIG. 7 is a flowchart illustrating one embodiment of a method ofgenerating customizable data packages for delivery to requesting displaydevices, such as in response to receiving a request for certain sensorinformation from a display device. In one embodiment, a display devicemay request sensor information from the sensor electronics module,rather than waiting to receive a data package from the sensorelectronics module in response to triggering of an alert. For example, adisplay device, such as a mobile telephone, may be configured to requestcertain displayable sensor information up to once a day whenever themobile device is within Bluetooth range of the sensor electronicsmodule. Thus, the mobile telephone may receive displayable sensorinformation even when alerts having actions for delivery of displayablesensor information to the mobile telephone are not triggered. Dependingon embodiment, the method of FIG. 7 may include fewer or additionalblocks and blocks may be performed in a different order than isillustrated.

Beginning in block 710, the sensor electronics module periodicallyreceives sensor data from one or more sensors. As noted above, thesensor electronics module may be configured to receive data from anytype of sensor via any suitable wired and/or wireless communicationprotocols.

Next, in block 720, the received sensor data is stored. Depending onembodiment, sensor data may be stored for predetermined time periodsand/or predetermined quantities. For example, data from one sensor maybe removed from the sensor electronics module after it is more than 30days old, while data from another sensor may remain in the sensorelectronics module until storage space on the sensor electronics modulereaches a certain threshold.

Continuing to block 730, the sensor electronics module determines if arequest for displayable sensor information has been received from adisplay device. If no request for displayable sensor information hasbeen received, the method returns to block 710 where sensor data fromthe one or more sensors continues to be received. If, however, a requestfor displayable sensor information has been received from a displaydevice, or from another device, the method continues to block 740.

In block 740, the sensor electronics module determines if the requestfor displayable sensor information includes custom delivery options forthe displayable sensor information. For example, the delivery optionsmay include indications of particular sensor data and/or transformedsensor data that are to be included in the displayable sensorinformation, as well as possibly formatting instructions for thedisplayable sensor information.

If the request does include delivery options, the delivery options areselected in block 750. If, however, the request does not includedelivered options, the method continues to block 760, where defaultdelivery options are selected. In one embodiment, the default deliveryoptions comprise a standard set of displayable sensor information withformatting options that are compatible with many/most display devices.In another embodiment, default delivery options may be specific to oneor more attributes of the requesting display device, such as a type,make, or model of the display device. In other embodiments, the defaultdelivery options may be based on other attributes, such as a time of dayat which the request is received, a status of the requesting displaydevice, or a transmission protocol by which the data package will betransmitted to the requesting display device, for example. In otherembodiments, default delivery options may be determined based on anyother relevant factors.

In block 770, the sensor electronics module generates and/or retrievesthe requested content, such as sensor data and/or transformed sensordata, and formats the data according to the selected default and/orcustom delivery options. If delivery options were received in therequest, displayable sensor information is selected and formattedaccording to the receive delivered options. Alternatively, if nodelivery options were received in the request, displayable sensorinformation is selected and formatted according to one or more defaultdelivery options.

In block 780, the displayable sensor information is packaged into one ormore data packages and transmitted to the requesting display device. Inone embodiment, a requesting display device may indicate a differentrecipient of the requested displayable sensor information. For example,a first display device, e.g., a mobile telephone, may send a request fordisplayable sensor information to a sensor electronics module indicatingthat the requested displayable sensor information be transmitted to anotebook computer rather than, or in addition to, transmitting therequested displayable sensor information to the requesting mobiletelephone. In one embodiment, the request may include multiple sets ofdelivery options associated with multiple recipients of displayablesensor information.

FIG. 8 is a flowchart illustrating one embodiment of a method ofselecting delivery options for a data package based on one or more of aplurality of attributes. As noted above, delivery options may beassociated with one or more of a plurality of attributes associated witha triggered alert, a host, a time of day/week/month, a location of ahost, a recipient display device, a display device characteristic (e.g.,a type, model, and/or make of display device), and/or any other relevantcharacteristics. Thus, delivery options, such as what sensor data andtransformed sensor data should be included in the displayable sensorinformation, and how the displayable sensor information should beformatted for delivery, may be based on multiple characteristics.

The method of FIG. 8 illustrates selection of delivery optionsassociated with a few exemplary characteristics. The method of FIG. 8may be performed, for example as part of an alert action that isinitiated in response to triggering of an alert. Thus, in one embodimentthe method of FIG. 8 describes an exemplary method of selecting deliveryoptions for transmission of a data package to a particular deliverydevice in response to triggering of an alert. In other embodiments,delivery options may be selected based on any other characteristic. Therelationship of delivery options to the characteristics discussed below,as well as other characteristics, may be stored in any suitable datastructure, such as a database, a flat file, a spreadsheet, a textdocument, or any other file structure. Depending on the embodiment, themethod of FIG. 8 may include fewer or additional blocks and blocks maybe performed in a different order than is illustrated.

Beginning in block 810, the sensor electronics module determines if adelivery option is associated with a triggered alert. If a deliveryoption is associated with a triggered alert, the method continues toblock 815 wherein the appropriate delivery options are selected. Incertain embodiments, depending on the alert, certain sensor data and/ortransformed sensor data may be important to transmit to thecorresponding delivery device. For example, key information associatedwith a first alert may include a series of sensor data points from aglucose monitor, while key information associated with a second alertmay include transformed data indicating a 60 minute trend in the glucoselevel of the host. Thus, each alert may be associated with differentdisplayable sensor information and/or options for formatting thedisplayable sensor information.

Continuing to block 820, the sensor electronics module determines if adelivery option is associated with the delivery device and/or one ormore users of the delivery device. For sample, if an alert actionindicates that a data package should be transmitted to an electronicmedical records (EMR) system, a sensor electronics module may selectcertain displayable sensor information for delivery to the EMR.Similarly, if an alert action indicates that a data package should betransmitted to a cell phone, a sensor electronics module may selectdifferent (e.g. a much smaller subset) displayable sensor informationfor delivery to the cell phone. Additionally, the formatting of thedisplayable sensor information for delivery to an EMR and a cell phone,for example, may be customized by the sensor electronics module based onthe type of display device.

In certain embodiments, the sensor electronics module may determinerespective users of receiving displayed devices and customize thedisplayable sensor information transmitted to the respective displaydevices accordingly. For example, a mother of a diabetic child thatwears a sensor electronics module may always be interested in knowingthe location of her child when alerts are transmitted to her.Accordingly, if the sensor electronics module determines that the motheris the user of a receiving display device, whether the display device isa cell phone, a notebook computer, or desktop computer, for example, thesensor electronics module may include the child's location in thedisplayable sensor information that is included in the correspondingdata package. If delivery options are associated with the receivingdelivery device and/or the user of the delivery device, the methodcontinues to block 825 where the corresponding delivery options areselected.

Moving to block 830, the sensor electronics module determines if adelivery option is associated with a location of the host and/or thedelivery device. In one embodiment, the sensor electronics moduleincludes a global positioning system (GPS) sensor that determines anapproximate or precise location of the sensor electronics module. Inother embodiments, the sensor electronics module may include othercircuitry that determines a location of the sensor electronics module,such as using cell phone communication signals, for example. In oneembodiment, the delivery options for a data package may be modifiedbased on the current location of the associated host. For example, ifthe host is at home, the delivery options may indicate that a minimalset of displayable sensor information is included in the transmitteddata package. However, if the host is at an unknown location, thedelivery options may indicate that a more comprehensive set ofdisplayable sensor information is included in the transmitted datapackage. If delivery options are associated with the location of thepatient and/or recipient, the method continues to block 835 where thosedelivery options are selected.

Continuing to block 840, the sensor electronics module determines if adelivery option is associated with a temporal characteristics, such as atime of day or day of the week, for example. Thus, the delivery optionsmay be adjusted based on the time at which the alert is triggered. Forexample, if a near hypoglycemic alert is triggered at 7 a.m. and thehost typically eats breakfast at about 7:30 a.m., the delivery optionsmay indicate only a minimal set of displayable sensor information fortransmission to a display device of the host. However, if the nearhypoglycemic alert is triggered at 10 p.m., a more complete set ofdisplayable sensor information may be selected for transmission to thedisplay device of the host. Similarly, a display device, either of thehost or another interested party, may receive data packages withdisplayable sensor information that is customized based on the day ofthe week on which the corresponding alert was triggered. For example,the content of displayable sensor information may vary depending onwhether the alert is triggered on a weekday or a weekend. If deliveryoptions are associated with the one or more temporal characteristics themethod continues to block 845 where those temporal characteristics areselected.

Next, in block 850 the sensor electronics module generates a datapackage according to the selected delivery options (e.g., in blocks 815,825, 835, 845) and initiates transmission of the data package to thedelivery device indicated in the delivery action. Accordingly, the datapackage comprises displayable sensor information that is customizedbased on one or more of multiple parameters, including those parametersdiscussed with respect to FIG. 8, elsewhere in this specification, andany other relevant parameters.

In other embodiments, certain delivery options may be included as alertconditions of respective alerts. Thus, if a delivery option is includedas an alert condition (e.g., do not deliver data packages during acertain time period), the alert would not trigger unless the alertcondition is satisfied.

FIG. 9 is a flowchart illustrating one embodiment of a method ofgenerating and transmitting a data package that is customized accordingto a status of the host and/or a status of the receiving display device.For example, statuses may include one or more of resting, exercise, donot disturb, illness, menstruation, mealtime, snooze, day, night,hyperglycemia, hypoglycemia, clinical risk, noise, and the like. In oneembodiment, different statuses of the host indicate to the sensorelectronics changes in how sensor data should be analyzed, such as howtransformed sensor data is determined. Depending on the embodiment,statuses of the host may be automatically detected by the sensorelectronics module, other sensors or devices associated with the host,and/or display device of the host. For example, an accelerometer thatcommunicates with the sensor electronics module may provide data that isindicative of running motion, such that the sensor electronics moduledetermines that a status of the host is “exercise” or the like. Statusesmay also be determined from other sensor data, such as transformedsensor data, from a glucose sensor, for example. Additionally, statusesof the host and/or display devices (or the user of the display device)may be changed according to a status schedule, such as a scheduleindicating that the host should be in sleep mode from 10 pm to 7 am eachnight and that a particular display device is in do not disturb modefrom 1 pm to 4 pm Monday through Friday. In other embodiments, thestatus of a host may be provided by the host (or caretaker of the host)via a user interface of the sensor electronics module or a displaydevice. For example, a display device of the host may include aninterface that allows the host to select from a group of statuses, suchas by scrolling through a list of status indicators (graphical and/ortextual). Any other suitable user interface may also be used forselecting statuses and/or creating new statuses. In one embodiment, atimer may be associated with a status change such that after anindicated time period the status of the host returns to a defaultstatus. For example, a host may change their status to “exercise” whenentering a gym for a one hour training session and may associate a 60minute (or slightly longer) timer with the status so that their statusis returned to a default status automatically after the workout iscomplete.

In one embodiment, the status of the host may affect alert conditionsassociated with one or more alerts, such that certain sensor data and/orcertain transformed sensor data might trigger an alert when the host isin a first status, but would not trigger an alert when the host is in asecond status. For example, when a person is exercising, his/her glucoselevels may increase or decrease in trends that would be abnormal underany other circumstances; by setting the appropriate status, the sensorelectronics module is configured to modify its processing associatedwith the user in a particular status, e.g., “exercise status” to triggeralerts, analyte estimates, trend information, therapy recommendations,and the like, customized with one or more criteria associated withexercise. Additional disclosure of statuses that are associated with ahost of a glucose sensor are discussed in commonly own U.S. patentapplication Ser. No. 12/258,345, entitled “systems and methods forprocesses sensory data,” filed on Oct. 24, 2008, which is herebyincorporated by reference in its entirety.

In one embodiment, a user (e.g., the host to which the sensorelectronics module is coupled) may enter events in real time (orretrospectively) in a display device and the events may be transmittedto the sensor electronics module. In one embodiment, the events areuseful when the historical sensor data and/or transformed sensor data islater analyzed. Events may be entered to indicate when a particularaction was taken by the host, such as when carbohydrates were consumed,when insulin was taken, when exercise was performed, when any relevantchange in the health of the host occurs, and/or any other event thatmight possible effect the sensor data. These events may include moredetailed information regarding the respective event, such as anindication of an insulin dosage associated with an insulin event or anindication of a particular type of exercise performed and a totalexercise time that are associated with an exercise event. The eventscould then be represented textually and/or pictorially in thedisplayable sensor information that is transmitted to display devices.Accordingly, triggering of an alert that would otherwise raise greatconcern may not be as worrisome when events surrounding the alerttrigger are viewable by the user of the display device.

In some embodiments, the event data may be used to modify when alertsare triggered and/or when/how data packages are transmitted torespective display devices. For example, entry of an event may causeadjustments to algorithms that are used in real-time generation oftransformed sensor data. Thus, similar to the use of statuses discussedabove, the events associated with the host may be used in the real-timedetermination of alert triggers and delivery of displayable sensorinformation, as well as being useful in later analysis of sensorinformation associated with the host.

In the method of FIG. 9, statuses are associated with display devices sothat the delivery options for transmitting a data package to a displaydevice may be modified according to a current status of the receivingdisplay device. Depending on embodiment, the method of FIG. 9 mayinclude fewer or additional blocks and the blocks may be performed in adifferent order that is illustrated.

Beginning in block 910, the sensor electronics module determines if analert is triggered. As discussed above, alerts may be triggered based onraw sensor data, transformed sensor data (e.g., calibrated and/orfiltered data), or any other data from one or more sensors.

Next, in block 920, the sensor electronics module identifies a deliveryaction associated with a triggered alert. As discussed above, a deliveryaction is a specific type of action wherein a data package comprisingdisplayable sensor information is generated and transmitted to anindicated display device. Thus, with identification of a deliveryaction, a corresponding display device is also identified in block 920.

Continuing to block 930, the sensor electronics module determines acurrent status of a display device indicated in the identified deliveryaction. In one embodiment, a status of certain display devices may bedetermined without receiving real-time information from the respectivedisplay device. For example, a status schedule indicating statuses of adisplay device that are associated with various times/dates may beaccessed in order to determine a current status of the display device.Similarly, a status rule may indicate that a particular display deviceis always in night status between 9 p.m. and 9 a.m. Other formats andtypes of status schedules may also be used.

In one embodiment, the sensor electronics module determines a currentstatus of the display device by requesting status information from thedisplay device. For example, a status request signal may be transmittedto the display device (or to a service provider associated with thedisplay device or another device that maintains updated statusinformation) prior to transmission of the indicated data package. In oneembodiment, the status request signal does not cause the display deviceto perform any functions that are readily detectable by the user of thedisplay device, but only causes the display device to respond to thesensor electronics module with an indication of a current status of thedisplay device. Thus, the sensor electronics module may determine astatus of the display device without interrupting the user of thedisplay device in the event that a current status of the display deviceindicates that the user does not wish to be interrupted with datapackages (or at least data packages associated with certain types ofalerts). In some embodiments, the display device may transmit anindication of when the current status will change to a different status,such as when a sleep status will change to an awake status. Thus, thesensor electronics module may delay transmission of a data package untilthe display device is in a status wherein transmission of the datapackage is appropriate. In other embodiments, a status of a displaydevice may be determined in any other manner.

Moving to block 940, the sensor electronics module determines deliveryoptions associated with the current status of the display device. Forexample, certain statuses may include no delivery options, such that thedelivery options already associated with the delivery action are used ingenerating the data package. Other statuses, however may includedelivery options that limit or expand the content of the displayablesensor information, adjust the formatting of the displayable sensorinformation, and/or adjust the method by which the displayable sensorinformation is transmitted to the display device. Accordingly, the userof the display device may customize the displayable sensor informationthat is delivered to the display device by adjusting a status of thedisplay device.

Continuing to block 950, the sensor electronics module initiatestransmission of the data package that is generated according to thedelivery options associated with the current status of the displaydevice. In some embodiments, certain statuses may cause the sensorelectronics module to not generate a data package for transmission tothe delivery device in response.

Next, in block 960, the sensor electronics module determines ifadditional delivery actions are associated with the triggered alert. Forexample, certain alerts have multiple associated delivery actions, eachindicating delivery options for respective display devices. If thetriggered alert is associated with one or more additional deliveryactions, the method returns to blocks 920-950 wherein the status ofanother display device is determined and an appropriate data package, ifany, is generated and transmitted.

FIGS. 10A and 10B are block diagrams illustrating one embodiment of asensor module 1012 that is configured to alternatively couple with eachof a plurality of modular devices 1020, 1030, 1040, 1050, 1060, and/orother devices, each having different functionalities. FIG. 10Aillustrates the sensor module 1012 along with multiple modular devicesthat may be alternately attached to the sensor module 1000 and FIG. 10Billustrates exemplary components of a sensor module 1012. As illustratedin FIG. 10B, the sensor module 1012 comprises fewer components than thesensor electronics module 12 of FIG. 2, for example. Accordingly, thesensor module 1012 may be a much smaller device that is less bothersometo the host. Advantageously, however, a host may attach modular devicesto the sensor module 1004 in order to allow the sensor module 1012 toperform additional functions.

The exemplary sensor module 1012 comprises a sensor 1014, which may beintegral to the sensor module 1012 or may be attached to one or moreelectrodes (or other connection port) of the sensor module 1012. Thesensor module 1012 also includes a processor 1018, such as aconventional microprocessor, an ASIC, an FPGA, or any other processinglogic, as well as a storage device 1016 that stores sensor data from thesensor 1014 and possibly transformed sensor data that is determined bythe processor 1018. In one embodiment, the storage device 1016 isconfigured to store only a small portion of the data that data storagememory 220 of the sensor electronic module 12 (FIG. 2) is configured tostore.

Advantageously, the sensor module 1012 comprises a module interface 1019comprising both a physical and an electrical interface for coupling withmodular devices, such as those of FIG. 10A. For example, the moduleinterface 1019 may be configured such that a modular device mayreleasably lock into attachment with the sensor module 1012.Additionally, in certain embodiments the coupling of the modular deviceswith the module interface 1019 causes one or more electrical contacts ofeach component to engage in order to communicate data between the sensormodule 1012 and the respective modular device.

Modular devices that may be coupled to the sensor module 1012 varygreatly and may include a Wi-Fi/Bluetooth module 1020 that is configuredto add additional communication capabilities to the sensor module 1012.In other embodiments, the module 1020 may be configured to communicateusing additional communication protocols. With the module 1020 attachedto the sensor module 1012, the sensor module 1012 may transmit datapackages, such as in response to triggered alerts, to one or moredisplay devices using Wi-Fi, ANT and/or Bluetooth communications.Another modular device is a GPS module 1030 that provides location datato the sensor module 1012. As described above, in certain embodimentslocation conditions are included in alert conditions for certain alertsand might be included in displayable sensor information that istransmitted to one or more display devices. Thus, the sensor module 1012may use the location data from the GPS module 1030 in order to determineif such alert conditions have been met.

Modular devices that may be attached to the sensor module 1012 may alsoinclude a display device 1040, which may include any size of displaypanel, such as an LCD or OLED display, for example. Depending on theembodiment, the display module 1040 may be able to display differenttypes of displayable sensor information formatted using variousformatting options. A sensor electronics module 1060 comprisingadditional processing logic, data storage space, and user interfacecontrols, for example, may also be removably coupled to the sensormodule 1012. Depending on embodiment, the sensor electronics module 1060may have all, or some subset of, the features discussed herein withrespect to other sensor electronics modules. In one embodiment, aglucose meter reference module 1050 may be coupled to the sensor module1012. The glucose meter reference module 1050 may be configured todetermine a reference glucose level of the host in order to calibratethe sensor data received from the sensor 1014.

In one embodiment, the sensor module 1012 also includes an alarm device,such as a light or speaker that is activated in response to triggeringof certain alerts. Thus, if an alert is triggered, such as based onsensor data and/or GPS location data provided by the GPS module 1030,the sensor module 1012 may activate a light of the sensor module 1012 inorder to alert the host to the triggering of the alarm. Depending onembodiment, different patterns of activation/deactivation of the lightand/or speaker may be used to indicate triggering of different alerts.

FIG. 11 illustrates an exemplary user interface 1100 for defining alertconditions. In one embodiment, default alert conditions (e.g., thatmight be set by a manufacturer of the sensor electronics module) areused in determining whether alerts have been triggered. In otherembodiments, a user of the sensor electronics module, such as the hostor a guardian of the host, for example, may establish custom alertshaving user-defined alert conditions. In the embodiment of FIG. 11, theuser provides an alert ID 1110 and minimum and/or maximum thresholdlevels for each of one or more sensors data or transformed sensor data.In embodiment of FIG. 11, alert conditions for three sensors, namely, aglucose sensor, a temperature sensor and a pulse sensor, may beestablished. In other embodiments, fewer or additional sensors may beincluded in a similar user interface in order to allow defining alertconditions based on those sensors.

The exemplary user interface 1100 includes a glucose conditions portion1120, a temperature conditions portions 1130, and a pulse conditionsportion 1140, where each of the portions allow the user to setconditions associated with the respective sensor data and/or transformedsensor data. In the embodiment of FIG. 11, the alert ID provided by theuser is “Hypo1”, which may be triggered in order to indicate that thehost is approaching hypoglycemia. In this embodiment, the user has set aglucose condition requiring that the glucose level is less than 70 mg/dLand that a rate of change of the glucose level (in mg/dL/min) is lessthan five. Each of these conditions associated with a glucose sensordata must be met in order for the Hypo1 alert to trigger. In the exampleof FIG. 11, the user interface 1100 does not include any conditionsassociated with a temperature sensor. However, in other embodimentsalert conditions associated with a current temperature of the host,temperature change trends, and/or any other transformed sensor dataassociated with a temperature sensor, may be included in an alertcondition.

The pulse conditions portion 1140 indicates that the pulse of the hostmust be below 80 beats per minute and the pulse must have changed atleast 15 beats per minute over the last five minutes. Accordingly, basedon the conditions indicated in exemplary FIG. 11, the Hypo1 alert istriggered when the glucose level of the host is 70 or below, the glucoserate of change is five or below, the pulse is 80 or below, and the pulsehas changed at least 15 beats per minute over a five minute period. Inother embodiments, other conditions associated with other sensors may beestablished in a similar manner. Once the user is satisfied with thealert conditions, a save button 1150 may be selected in order to storethe newly defined alert in a data structure that is accessible to thesensor electronics module.

FIG. 12 illustrates an exemplary user interface 1200 for definingdisplay device characteristics. In certain embodiments, delivery optionsare determined based on a type, make, model, or other characteristic ofa display device. Thus, in certain embodiments, characteristics ofdisplay devices that are available to receive data packages from thesensor electronics module may be defined so that the sensor electronicsmodule may determined delivery options for respective display devices.Additionally, in certain embodiments alert conditions may be based onone or more characteristics of a display device.

In the embodiment of FIG. 12, a user supplies a device ID 1210, a devicetype 1220, a device manufacturer 1230, and a device model 1240 via anysuitable data entry controls. For example, a device type may be providedvia a drop-down list wherein the user can select a type of displaydevice from a series of listed display devices. Similarly, a devicemanufacturer and device model may be selected by drop-down lists wherethe options illustrated in the drop-down lists are narrowed as moregeneral information regarding the device is received. For example, oncea user selects a device type, the choices of device manufacturers may benarrowed to only those device manufacturers that manufacture theselected device type. In other embodiments, fewer or additional devicecharacteristics may be provided by the user. When the appropriate devicecharacteristics are selected, the user selects a save button 1250 thatinitiates the storage of the device characteristics in a data structurethat is accessible by the sensor electronics module.

FIG. 13 illustrates an exemplary user interface 1300 for establishingdelivery options associated with respective alerts and display devices.Using the user interface 1300, delivery options may be established forrespective display devices that are associated with respective alerts,such as customized alerts and/or default alerts. In the embodiment ofFIG. 13, a display device and an alert are selected in the deviceselection portion 1310 and alert selection portion 1320, respectively.In this embodiment, the devices that have been set up by a user, such asvia a user interface similar to that of FIG. 12, are listed in adrop-down box 1312. Similarly, the alerts that have been established bythe user, such as via the alert conditions interface 1100 of FIG. 11and/or other default alerts are displayed for selection in an alertdrop-down box 1314.

In the exemplary user interface 1300, the user has selected the“joesphone” display device to receive a data package in response totriggering of the Hypo1 alert. The lower portion of the user interface1300 allows the user to establish delivery options, such as which sensordata and/or transformed sensor data should be included in thedisplayable sensor information that is transmitted to the selecteddisplay device. In this embodiment, the user may select a minimum and/ormaximum frequency at which data packages associated with the selectedalert should be transmitted to the selected display device. Thefrequency of sending alerts may change depending on one or moreattributes of the sample data, the triggered alert, actions taken by thehost in response to the alert, a status of the host or display device,and any other characteristic of the host. For example, a data packageassociated with a severe hypoglycemia condition may be transmittedfrequently (e.g., every 5 minutes), while a data package associated witha near hypoglycemia condition may be transmitted only once each hour(assuming the alert conditions associated with near hypoglycemia arestill matched by the sensor data at each one hour interval).Additionally, the frequency of retransmitting data packages associatedwith an alert may accelerate (or decelerate) over time, such as sendinga severe hypoglycemia data package every minute for the first 10 minutesafter the alert conditions are matched and thereafter sending a datapackage every 5 minutes. Depending on the embodiment, (re)transmissionsof data packages that are associated with delivery options indicatingmultiple (re)transmissions of the data packages may be delayed and/orhalted in response to triggering of other alerts associated with thehost, performing of an action by the host, or actions by the receivingdisplay device. For example, delivery options may indicate that datapackages associated with a hyperglycemic condition are stopped inresponse to the host receiving insulin (either manually orautomatically). Additionally, a user of a particular display device mayindicate that they do not wish to receive further data packagesassociated with a triggered alert, such as after receiving a first datapackage including information regarding the triggered alert.

Additionally, the user may select displayable sensor information thatwill be transmitted to be selected display device in response totriggering of the selected alert. The data content portion 1340 listsonly a few of the content items that may be selected for inclusion indisplayable sensor information that is transmitted to the displaydevice. In other embodiments, the format of the selected data contentmay also be established in a user interface similar to that of FIG. 13.For example, a user may indicate whether a five-minute trend informationshould be formatted as a line graph, bar graph, pie graph, or in someother format. Accordingly, the user is provided great flexibility in howthe sensor electronics module transmits data to each of multiple displaydevices.

FIG. 14A illustrates a portion of an exemplary alert data structure1400. Although the data structures discussed herein are illustrated in aparticular arrangement in the corresponding drawings, the datastructures may include any other type and/or format of data structure,such as a database, a table, a flat file, a spreadsheet file, or anyother file that stores data. In the embodiment of FIG. 14A, the datastructure 1400 includes an alert ID column 1410, a display deviceaddress column 1420, a device type column 1430, and a frequency column1440. In this embodiment, when an alert is triggered, such as the alertslisted in column 1410, a delivery action is initiated, wherein agenerated data package is transmitted to each of the delivery addresseslisted in column 1420 that are associated with the triggered alert. Inthis embodiment, the delivery options associated with respective datapackages are determined based on the device type listed in column 1430.For example, FIG. 14B illustrates a delivery options data structure 1450that indicates particular data content to include in the transmitteddisplayable sensor information based on the device type indicated incolumn 1430. For example, the exemplary delivery options data structure1450 indicates that for a mobile device type, the displayable sensorinformation includes a 10 minute trend and a one hour trend. In otherembodiments, the delivery options data structure also includesformatting options for particular content.

Returning to FIG. 14A, the frequency column 1440 indicates a maximum(and/or minimum) frequency at which data packages should be transmittedto the corresponding delivery addresses (in column 1420, for example).Thus, the hypoglycemic alert of FIG. 14 triggers a delivery action tosix different delivery addresses, including Joe@MSN.com,Linda@e-mail.com, ftp://admin:pass@123.12.12.42, etc. Thus, when thehypoglycemic alert is triggered, data packages comprising displayablesensor information that is selected based on a type of display to whichthe data package is to be sent are generated. Accordingly, the datapackage that is delivered to joe@MSN.com is generated based on thedisplay device characteristics for a mobile device, such as those incolumn 1460 of FIG. 14B. Similarly, the delivery options for the datapackage that is transmitted to Linda@e-mail.com, which column 1430indicates is associated with a PC, are determined based on the deliveryoptions of column 1470 in FIG. 14B.

FIGS. 15A and 15B illustrate exemplary data structures that may be usedto establish alerts, detect when alert conditions are met, and generatecustomized data packages for different display devices based on one ormore of multiple factors. FIG. 15A illustrates a device data structure1500 that stores device characteristics associated with each of one ormore device IDs. In one embodiment, the data of FIG. 15A is provided bya user via a user interface, such as user interface of FIG. 12. Theexemplary data structure 1500 comprises a device ID column 1510 thatlists a device ID that is specific to a particular display device, adevice address column 1512 that indicates an address to which the datapackage for the corresponding display device should be delivered, adevice type column 1514 that indicates a type of device, and a devicemodel column 1516 that indicates a model of the particular device. Inother embodiments, fewer or additional characteristics of the devicesmay be included in a similar data structure.

FIG. 15B illustrates an alert data structure 1520 that provides alertactions corresponding with each of a plurality of alerts, as well asdelivery options for specific display devices indicated in the alertactions. In particular, the data structure 1520 includes an alert column1522 that includes an alert ID of the alerts for which alert actions areto be performed. An alert action column 1524 lists an action that shouldbe performed when the corresponding alert is triggered, such as a deviceID associated with a delivery action. In this embodiment, the devicecharacteristics may be determined by accessing the data structure of15A, for example. The data structure 1520 also includes a plurality ofdelivery options in columns 1530. As discussed above, delivery optionsmay include indications of the content of sensor data and/or transformedsensor data that should be included in the displayable sensorinformation transmitted to a display device, as well as limits on thefrequency at which such data packages are transmitted to the displaydevice, and/or formatting options for the displayable sensorinformation.

FIG. 16 is a multi-sensor alert data structure 1600 storing alertconditions associated with multiple sensors in alert conditions section1610. Thus, the data structure of FIG. 16 defines alert conditions incolumns 1610 and includes a device ID and column 1620 that may be usedto indicate display device and specific delivery options for delivery ofdata packages in response to triggering of alerts. In one embodiment,delivery options may also be customized based on the type of device towhich a data package is transmitted, where device characteristics may bedetermined using a table such as that of FIG. 15A.

In other embodiments, various other arrangements of data may be utilizedto allow the sensor electronics module to customize displayable sensordata for each of a plurality of display devices in response totriggering of alerts (that may be customized also).

Methods and devices that are suitable for use in conjunction withaspects of the preferred embodiments are disclosed in U.S. Pat. No.4,994,167; U.S. Pat. No. 4,757,022; U.S. Pat. No. 6,001,067; U.S. Pat.No. 6,741,877; U.S. Pat. No. 6,702,857; U.S. Pat. No. 6,558,321; U.S.Pat. No. 6,931,327; U.S. Pat. No. 6,862,465; U.S. Pat. No. 7,074,307;U.S. Pat. No. 7,081,195; U.S. Pat. No. 7,108,778; U.S. Pat. No.7,110,803; U.S. Pat. No. 7,192,450; U.S. Pat. No. 7,226,978; and U.S.Pat. No. 7,310,544.

Methods and devices that are suitable for use in conjunction withaspects of the preferred embodiments are disclosed in U.S. PatentPublication No. US-2005-0176136-A1; U.S. Patent Publication No.US-2005-0251083-A1; U.S. Patent Publication No. US-2005-0143635-A1; U.S.Patent Publication No. US-2005-0181012-A1; U.S. Patent Publication No.US-2005-0177036-A1; U.S. Patent Publication No. US-2005-0124873-A1; U.S.Patent Publication No. US-2005-0115832-A1; U.S. Patent Publication No.US-2005-0245799-A1; U.S. Patent Publication No. US-2005-0245795-A1; U.S.Patent Publication No. US-2005-0242479-A1; U.S. Patent Publication No.US-2005-0182451-A1; U.S. Patent Publication No. US-2005-0056552-A1; U.S.Patent Publication No. US-2005-0192557-A1; U.S. Patent Publication No.US-2005-0154271-A1; U.S. Patent Publication No. US-2004-0199059-A1; U.S.Patent Publication No. US-2005-0054909-A1; U.S. Patent Publication No.US-2005-0051427-A1; U.S. Patent Publication No. US-2003-0032874-A1; U.S.Patent Publication No. US-2005-0103625-A1; U.S. Patent Publication No.US-2005-0203360-A1; U.S. Patent Publication No. US-2005-0090607-A1; U.S.Patent Publication No. US-2005-0187720-A1; U.S. Patent Publication No.US-2005-0161346-A1; U.S. Patent Publication No. US-2006-0015020-A1; U.S.Patent Publication No. US-2005-0043598-A1; U.S. Patent Publication No.US-2005-0033132-A1; U.S. Patent Publication No. US-2005-0031689-A1; U.S.Patent Publication No. US-2004-0186362-A1; U.S. Patent Publication No.US-2005-0027463-A1; U.S. Patent Publication No. US-2005-0027181-A1; U.S.Patent Publication No. US-2005-0027180-A1; U.S. Patent Publication No.US-2006-0020187-A1; U.S. Patent Publication No. US-2006-0036142-A1; U.S.Patent Publication No. US-2006-0020192-A1; U.S. Patent Publication No.US-2006-0036143-A1; U.S. Patent Publication No. US-2006-0036140-A1; U.S.Patent Publication No. US-2006-0019327-A1; U.S. Patent Publication No.US-2006-0020186-A1; U.S. Patent Publication No. US-2006-0036139-A1; U.S.Patent Publication No. US-2006-0020191-A1; U.S. Patent Publication No.US-2006-0020188-A1; U.S. Patent Publication No. US-2006-0036141-A1; U.S.Patent Publication No. US-2006-0020190-A1; U.S. Patent Publication No.US-2006-0036145-A1; U.S. Patent Publication No. US-2006-0036144-A1; U.S.Patent Publication No. US-2006-0016700-A1; U.S. Patent Publication No.US-2006-0142651-A1; U.S. Patent Publication No. US-2006-0086624-A1; U.S.Patent Publication No. US-2006-0068208-A1; U.S. Patent Publication No.US-2006-0040402-A1; U.S. Patent Publication No. US-2006-0036142-A1; U.S.Patent Publication No. US-2006-0036141-A1; U.S. Patent Publication No.US-2006-0036143-A1; U.S. Patent Publication No. US-2006-0036140-A1; U.S.Patent Publication No. US-2006-0036139-A1; U.S. Patent Publication No.US-2006-0142651-A1; U.S. Patent Publication No. US-2006-0036145-A1; U.S.Patent Publication No. US-2006-0036144-A1; U.S. Patent Publication No.US-2006-0200022-A1; U.S. Patent Publication No. US-2006-0198864-A1; U.S.Patent Publication No. US-2006-0200019-A1; U.S. Patent Publication No.US-2006-0189856-A1; U.S. Patent Publication No. US-2006-0200020-A1; U.S.Patent Publication No. US-2006-0200970-A1; U.S. Patent Publication No.US-2006-0183984-A1; U.S. Patent Publication No. US-2006-0183985-A1; U.S.Patent Publication No. US-2006-0195029-A1; U.S. Patent Publication No.US-2006-0229512-A1; U.S. Patent Publication No. US-2006-0222566-A1; U.S.Patent Publication No. US-2007-0032706-A1; U.S. Patent Publication No.US-2007-0016381-A1; U.S. Patent Publication No. US-2007-0027370-A1; U.S.Patent Publication No. US-2007-0027384-A1; U.S. Patent Publication No.US-2007-0032717-A1; U.S. Patent Publication No. US-2007-0032718-A1; U.S.Patent Publication No. US-2007-0059196-A1; U.S. Patent Publication No.US-2007-0066873-A1; U.S. Patent Publication No. US-2007-0093704-A1; U.S.Patent Publication No. US-2007-0197890-A1; U.S. Patent Publication No.US-2007-0173710-A1; U.S. Patent Publication No. US-2007-0163880-A1; U.S.Patent Publication No. US-2007-0203966-A1; U.S. Patent Publication No.US-2007-0213611-A1; U.S. Patent Publication No. US-2007-0232879-A1; U.S.Patent Publication No. US-2007-0235331-A1; U.S. Patent Publication No.US-2008-0021666-A1; and U.S. Patent Publication No. US-2008-0033254-A1.

Methods and devices that are suitable for use in conjunction withaspects of the preferred embodiments are disclosed in U.S. patentapplication Ser. No. 09/447,227 filed Nov. 22, 1999 and entitled “DEVICEAND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. patent application Ser.No. 11/654,135 filed Jan. 17, 2007 and entitled “POROUS MEMBRANES FORUSE WITH IMPLANTABLE DEVICES”; U.S. patent application Ser. No.11/654,140 filed Jan. 17, 2007 and entitled “MEMBRANES FOR AN ANALYTESENSOR”; U.S. patent application Ser. No. 11/543,396 filed Oct. 4, 2006and entitled “ANALYTE SENSOR”; U.S. patent application Ser. No.11/543,490 filed Oct. 4, 2006 and entitled “ANALYTE SENSOR”; U.S. patentapplication Ser. No. 11/543,404 filed Oct. 4, 2006 and entitled “ANALYTESENSOR”; U.S. patent application Ser. No. 11/691,426 filed Mar. 26, 2007and entitled “ANALYTE SENSOR”; U.S. patent application Ser. No.11/691,432 filed Mar. 26, 2007 and entitled “ANALYTE SENSOR”; U.S.patent application Ser. No. 11/691,424 filed Mar. 26, 2007 and entitled“ANALYTE SENSOR”; and U.S. patent application Ser. No. 11/691,466 filedMar. 26, 2007 and entitled “ANALYTE SENSOR”.

All references cited herein, including but not limited to published andunpublished applications, patents, and literature references, areincorporated herein by reference in their entirety and are hereby made apart of this specification. To the extent publications and patents orpatent applications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term “about.” Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

The above description discloses several methods and materials of thepresent invention. This invention is susceptible to modifications in themethods and materials, as well as alterations in the fabrication methodsand equipment. Such modifications will become apparent to those skilledin the art from a consideration of this disclosure or practice of theinvention disclosed herein. Consequently, it is not intended that thisinvention be limited to the specific embodiments disclosed herein, butthat it cover all modifications and alternatives coming within the truescope and spirit of the invention.

1. A key fob device sized to fit on a key chain and configured tooperably connect to a continuous analyte sensor, wherein the key fobdevice comprises a telemetry module, a data storage device and a userinterface, wherein the telemetry module is configured to wirelesslyreceive sensor data from a continuous analyte sensor and to transmitsensor data to a secondary display device, wherein the data storagedevice is configured to store sensor data, and wherein the key fobdevice is configured to display sensor data on the user interface. 2.The key fob device of claim 1, further comprising an authenticationmechanism.
 3. The key fob device of claim 1, wherein the sensor datatransmitted to the secondary display device comprises displayable sensorinformation.
 4. The key fob device of claim 1, wherein the sensor datareceived from the continuous analyte sensor comprises displayable sensorinformation.
 5. The key fob device of claim 1, wherein the processormodule is configured to process sensor data from the continuous analytesensor to provide displayable sensor information.
 6. The key fob deviceof claim 1, wherein the key fob device is configured to receive userinput.
 7. The key fob device of claim 6, wherein the user interfacecomprises one or more buttons configured to accept the user input. 8.The key fob device of claim 6, wherein the user input comprisescalibration information.
 9. The key fob device of claim 6, wherein thekey fob device is configured to wirelessly transmit the user input tothe continuous analyte sensor.
 10. The key fob device of claim 1,wherein the key fob device is configured to display, on the userinterface, a number representative of the analyte concentration based onthe sensor data.
 11. The key fob device of claim 10, wherein the key fobdevice is configured to display, on the user interface, an arrowrepresentative of a rate of change of the analyte concentration based onthe sensor data.
 12. The key fob device of claim 1, further comprising aUSB connector and a telemetry adapter configured to enable directwireless access between the sensor electronics module and a personalcomputer.
 13. The key fob device of claim 1, wherein the telemetrymodule is configured to transmit sensor data wirelessly.
 14. The key fobdevice of claim 13, wherein the telemetry module is configured towirelessly transmit sensor data using a standardized wireless protocol.15. The key fob device of claim 14, wherein the standardized wirelessprotocol is a Bluetooth protocol.
 16. The key fob device of claim 14,wherein the key fob device is configured to wirelessly transmit sensordata to a telemetry module of a secondary display device having a userinterface configured to display more sensor data than the user interfaceof the key fob device.
 17. The key fob device of claim 16, wherein thetelemetry module of the secondary display device is configured towirelessly receive sensor data using a standardized wireless protocol.18. The key fob device of claim 17, wherein the standardized wirelessprotocol is a Bluetooth protocol.
 19. The key fob device of claim 16,wherein the secondary display device comprises a phone.
 20. The key fobdevice of claim 1, wherein the sensor data comprises sensor datarepresentative of a glucose concentration in a host.
 21. The key fobdevice of claim 1, wherein the key fob device is configured to audibly,visibly or tactilely alert a user in response to one or more alertconditions being satisfied by the sensor data.
 22. The key fob device ofclaim 21, wherein the one or more alert conditions are user settable.23. The key fob device of claim 22, wherein the one or more alertconditions are user settable by the user into the user interface of thekey fob device.